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P50, P80 and P95 dates for every milestone in a device program, from your own plan and a reference-class library that names its sources, with a named human on every report.

Synthetic dataCalibration: SYNTHETICLLM: OFF
Program Balloon dilation catheter (synthetic demo) · run 20260330T120000Z-1a944fef
Download the demo forecast.json

Showing the synthetic demo: an invented Class II balloon dilation catheter program, twelve simulated weekly check-in cycles, two seeded slips. 6 of 8 milestones open as of 2026-03-30.

Milestones baseline · P50 · P80 · P95 · P(on baseline) · state · top driver
MilestoneBaselineP50P80P95P(on baseline)StateTop driver
Design inputs approved2026-01-272026-01-282026-01-28 (+1 d)2026-01-280%READYresolved 2026-01-28
Design freeze2026-02-282026-02-282026-02-28 (+0 d)2026-02-28100%READYresolved 2026-02-28
Pilot build complete2026-04-192026-06-132026-07-05 (+77 d)2026-08-040%BLOCKEDBalloon first-article inspection and approval 100% of late runs
Biocompatibility complete2026-04-202026-05-052026-05-14 (+24 d)2026-05-261%BLOCKEDCytotoxicity panel (ISO 10993-5) 92% of late runs
Sterilization and aging complete2026-07-112026-10-072026-11-18 (+130 d)2027-01-130%BLOCKEDEO sterilization validation (ISO 11135) execution 67% of late runs
Design verification complete2026-05-212026-08-032026-08-30 (+101 d)2026-10-050%BLOCKEDBalloon first-article inspection and approval 100% of late runs
510(k) submitted2026-08-122026-11-162026-12-29 (+139 d)2027-02-210%BLOCKEDEO sterilization validation (ISO 11135) execution 63% of late runs
510(k) cleared2027-01-092027-04-062027-08-14 (+217 d)2028-04-2017%BLOCKEDFDA 510(k) review to decision 100% of late runs
Gantt dashed baseline · solid P50 · P50→P95 band · critical path outlined · as-of line
Feb 26 Mar 26 Apr 26 May 26 Jun 26 Jul 26 Aug 26 Sep 26 Oct 26 Nov 26 Dec 26 Jan 27 Feb 27 Mar 27 Apr 27 May 27 Jun 27 Jul 27 Aug 27 Sep 27 Oct 27 Nov 27 Dec 27 Jan 28 Feb 28 Mar 28 Apr 28 as of 2026-03-30 Kick-off and charter approval T001 Kick-off and charter approval class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-05 → 2026-01-08 P50 2026-01-09 · P80 2026-01-09 · P95 2026-01-09 last check-in: none Voice-of-customer interviews (int… T002 Voice-of-customer interviews (interventional) class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-08 → 2026-01-16 P50 2026-01-16 · P80 2026-01-16 · P95 2026-01-16 last check-in: 2026-01-12 by Clinical Lead Intended use and indications stat… T003 Intended use and indications statement class: design_input_review (rule) prior source: TODO(founder): design-control cycle times from published PMO benchmarks; placeholder status: done 100% baseline 2026-01-16 → 2026-01-20 P50 2026-01-18 · P80 2026-01-18 · P95 2026-01-18 last check-in: 2026-01-19 by Regulatory Lead Product requirements document dra… T004 Product requirements document draft class: design_input_review (rule) prior source: TODO(founder): design-control cycle times from published PMO benchmarks; placeholder status: done 100% baseline 2026-01-16 → 2026-01-22 P50 2026-01-23 · P80 2026-01-23 · P95 2026-01-23 last check-in: 2026-01-19 by R&D Lead Design input review and approval T005 Design input review and approval class: design_input_review (rule) prior source: TODO(founder): design-control cycle times from published PMO benchmarks; placeholder status: done 100% baseline 2026-01-22 → 2026-01-27 P50 2026-01-28 · P80 2026-01-28 · P95 2026-01-28 last check-in: none Regulatory strategy memo (510(k),… T006 Regulatory strategy memo (510(k), product code) class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-20 → 2026-01-25 P50 2026-01-26 · P80 2026-01-26 · P95 2026-01-26 last check-in: 2026-01-26 by Regulatory Lead Design inputs approved baseline 2026-01-27 M1 Design inputs approved class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: done 100% baseline 2026-01-27 → 2026-01-27 P50 2026-01-28 · P80 2026-01-28 · P95 2026-01-28 last check-in: none P80 2026-01-28 · READY Pre-Sub decision memo T007 Pre-Sub decision memo class: presub_qsub (rule) prior source: TODO(founder): FDA Q-Sub guidance timeframes; placeholder status: done 100% baseline 2026-01-25 → 2026-01-30 P50 2026-01-30 · P80 2026-01-30 · P95 2026-01-30 last check-in: 2026-01-26 by Regulatory Lead Risk management plan (ISO 14971) T008 Risk management plan (ISO 14971) class: risk_management_file (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-01-27 → 2026-01-31 P50 2026-01-31 · P80 2026-01-31 · P95 2026-01-31 last check-in: 2026-02-02 by Quality Engineer Preliminary hazard analysis T009 Preliminary hazard analysis class: risk_management_file (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-01-31 → 2026-02-06 P50 2026-02-09 · P80 2026-02-09 · P95 2026-02-09 last check-in: 2026-02-02 by Quality Engineer Balloon material and wall-thickne… T010 Balloon material and wall-thickness trade study class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-27 → 2026-02-02 P50 2026-01-31 · P80 2026-01-31 · P95 2026-01-31 last check-in: 2026-02-02 by R&D Lead Shaft and hub concept selection T011 Shaft and hub concept selection class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-27 → 2026-02-01 P50 2026-02-03 · P80 2026-02-03 · P95 2026-02-03 last check-in: 2026-02-02 by R&D Lead Catheter tip and marker band desi… T012 Catheter tip and marker band design class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-01 → 2026-02-05 P50 2026-02-05 · P80 2026-02-05 · P95 2026-02-05 last check-in: 2026-02-02 by R&D Lead Balloon compliance model and simu… T013 Balloon compliance model and simulation class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-02 → 2026-02-07 P50 2026-02-07 · P80 2026-02-07 · P95 2026-02-07 last check-in: 2026-02-09 by R&D Lead Prototype lot A build (hand-built) T014 Prototype lot A build (hand-built) class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-07 → 2026-02-13 P50 2026-02-15 · P80 2026-02-15 · P95 2026-02-15 last check-in: 2026-02-09 by Manufacturing Engineer Bench feasibility: burst and fati… T015 Bench feasibility: burst and fatigue screening class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-13 → 2026-02-18 P50 2026-02-17 · P80 2026-02-17 · P95 2026-02-17 last check-in: 2026-02-16 by Test Engineer Design FMEA update T016 Design FMEA update class: risk_management_file (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-18 → 2026-02-22 P50 2026-02-20 · P80 2026-02-20 · P95 2026-02-20 last check-in: 2026-02-23 by Quality Engineer Drawing package release (ECO) T017 Drawing package release (ECO) class: design_freeze (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-18 → 2026-02-23 P50 2026-02-23 · P80 2026-02-23 · P95 2026-02-23 last check-in: 2026-02-23 by R&D Lead Formal design review DR2 T018 Formal design review DR2 class: design_review_gate (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-23 → 2026-02-26 P50 2026-03-01 · P80 2026-03-01 · P95 2026-03-01 last check-in: 2026-02-23 by Program Manager Design freeze T019 Design freeze class: design_freeze (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-26 → 2026-02-28 P50 2026-02-28 · P80 2026-02-28 · P95 2026-02-28 last check-in: 2026-03-02 by R&D Lead Design freeze baseline 2026-02-28 M2 Design freeze class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: done 100% baseline 2026-02-28 → 2026-02-28 P50 2026-02-28 · P80 2026-02-28 · P95 2026-02-28 last check-in: none P80 2026-02-28 · READY Balloon supplier selection and qu… T020 Balloon supplier selection and quote class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-02 → 2026-02-08 P50 2026-02-09 · P80 2026-02-09 · P95 2026-02-09 last check-in: 2026-02-09 by Supplier Quality Balloon supplier quality agreement T021 Balloon supplier quality agreement class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-08 → 2026-02-20 P50 2026-02-19 · P80 2026-02-19 · P95 2026-02-19 last check-in: 2026-02-16 by Supplier Quality Balloon tooling fabrication T022 Balloon tooling fabrication class: tooling_lead_time (rule) prior source: TODO(founder): placeholder status: in_progress 58% baseline 2026-02-23 → 2026-03-19 P50 2026-04-10 · P80 2026-04-16 · P95 2026-04-24 last check-in: 2026-03-09 by Supplier Quality Balloon first-article inspection … T023 Balloon first-article inspection and approval class: supplier_fai (rule) prior source: TODO(founder): placeholder status: blocked 20% baseline 2026-03-19 → 2026-04-02 P50 2026-05-21 · P80 2026-06-08 · P95 2026-07-06 last check-in: 2026-03-30 by Supplier Quality Extrusion supplier first-article … T024 Extrusion supplier first-article inspection class: supplier_fai (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-23 → 2026-03-07 P50 2026-03-07 · P80 2026-03-07 · P95 2026-03-07 last check-in: 2026-03-09 by Supplier Quality Hub and strain relief mold tooling T025 Hub and strain relief mold tooling class: tooling_lead_time (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-23 → 2026-03-23 P50 2026-03-25 · P80 2026-03-25 · P95 2026-03-25 last check-in: 2026-03-23 by Manufacturing Engineer Hub first-article inspection T026 Hub first-article inspection class: supplier_fai (rule) prior source: TODO(founder): placeholder status: in_progress 70% baseline 2026-03-23 → 2026-04-02 P50 2026-04-02 · P80 2026-04-05 · P95 2026-04-09 last check-in: 2026-03-30 by Supplier Quality Incoming inspection plans T027 Incoming inspection plans class: supplier_fai (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-20 → 2026-02-27 P50 2026-02-27 · P80 2026-02-27 · P95 2026-02-27 last check-in: 2026-02-23 by Quality Engineer Assembly fixture design T028 Assembly fixture design class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-23 → 2026-03-07 P50 2026-03-08 · P80 2026-03-08 · P95 2026-03-08 last check-in: 2026-03-09 by Manufacturing Engineer Assembly fixture fabrication T029 Assembly fixture fabrication class: tooling_lead_time (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-07 → 2026-03-27 P50 2026-03-25 · P80 2026-03-25 · P95 2026-03-25 last check-in: 2026-03-23 by Manufacturing Engineer Manufacturing procedure drafts T030 Manufacturing procedure drafts class: design_transfer (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-07 → 2026-03-17 P50 2026-03-18 · P80 2026-03-18 · P95 2026-03-18 last check-in: 2026-03-16 by Manufacturing Engineer Operator training T031 Operator training class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: in_progress 75% baseline 2026-03-27 → 2026-03-31 P50 2026-03-31 · P80 2026-03-31 · P95 2026-04-01 last check-in: none Pilot build lot P1 (DV units) T032 Pilot build lot P1 (DV units) class: pilot_build (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-02 → 2026-04-14 P50 2026-06-07 · P80 2026-06-27 · P95 2026-07-27 last check-in: none Pilot lot P1 inspection and relea… T033 Pilot lot P1 inspection and release class: pilot_build (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-14 → 2026-04-19 P50 2026-06-13 · P80 2026-07-05 · P95 2026-08-04 last check-in: none Pilot build complete baseline 2026-04-19 M3 Pilot build complete class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: not_started 0% baseline 2026-04-19 → 2026-04-19 P50 2026-06-13 · P80 2026-07-05 · P95 2026-08-04 last check-in: none P80 2026-07-05 · BLOCKED Biological evaluation plan (ISO 1… T034 Biological evaluation plan (ISO 10993-1) class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: done 100% baseline 2026-01-27 → 2026-02-02 P50 2026-02-03 · P80 2026-02-03 · P95 2026-02-03 last check-in: none Biocomp test article build and st… T035 Biocomp test article build and sterilization class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: done 100% baseline 2026-02-13 → 2026-02-19 P50 2026-02-20 · P80 2026-02-20 · P95 2026-02-20 last check-in: 2026-02-16 by Test Engineer Cytotoxicity panel (ISO 10993-5) T036 Cytotoxicity panel (ISO 10993-5) class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: in_progress 65% baseline 2026-02-19 → 2026-03-16 P50 2026-04-24 · P80 2026-05-03 · P95 2026-05-14 last check-in: 2026-03-30 by Test Engineer Sensitization and irritation pane… T037 Sensitization and irritation panel (ISO 10993-10/23) class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: in_progress 87% baseline 2026-02-19 → 2026-04-05 P50 2026-04-05 · P80 2026-04-08 · P95 2026-04-13 last check-in: 2026-03-30 by Test Engineer Hemocompatibility panel (ISO 1099… T038 Hemocompatibility panel (ISO 10993-4) class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: in_progress 95% baseline 2026-02-19 → 2026-03-31 P50 2026-04-01 · P80 2026-04-02 · P95 2026-04-04 last check-in: 2026-03-30 by Test Engineer Chemical characterization, extrac… T039 Chemical characterization, extractables (ISO 10993-18) class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: in_progress 78% baseline 2026-02-19 → 2026-04-10 P50 2026-04-11 · P80 2026-04-16 · P95 2026-04-26 last check-in: 2026-03-30 by Test Engineer Biological evaluation report T040 Biological evaluation report class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-04-10 → 2026-04-20 P50 2026-05-05 · P80 2026-05-14 · P95 2026-05-26 last check-in: none Biocompatibility complete baseline 2026-04-20 M4 Biocompatibility complete class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: not_started 0% baseline 2026-04-20 → 2026-04-20 P50 2026-05-05 · P80 2026-05-14 · P95 2026-05-26 last check-in: none P80 2026-05-14 · BLOCKED Sterilization method selection (E… T041 Sterilization method selection (EO) class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: done 100% baseline 2026-02-28 → 2026-03-05 P50 2026-03-08 · P80 2026-03-08 · P95 2026-03-08 last check-in: 2026-03-02 by Quality Engineer Sterilization validation protocol T042 Sterilization validation protocol class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: done 100% baseline 2026-03-05 → 2026-03-15 P50 2026-03-17 · P80 2026-03-17 · P95 2026-03-17 last check-in: 2026-03-16 by Quality Engineer EO sterilization validation (ISO … T043 EO sterilization validation (ISO 11135) execution class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: not_started 0% baseline 2026-04-14 → 2026-06-13 P50 2026-08-16 · P80 2026-09-27 · P95 2026-11-26 last check-in: none EO residuals testing (ISO 10993-7) T044 EO residuals testing (ISO 10993-7) class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: not_started 0% baseline 2026-06-13 → 2026-07-03 P50 2026-09-10 · P80 2026-10-24 · P95 2026-12-21 last check-in: none Packaging design and pouch select… T045 Packaging design and pouch selection class: package_validation (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-28 → 2026-03-10 P50 2026-03-09 · P80 2026-03-09 · P95 2026-03-09 last check-in: 2026-03-09 by Packaging Engineer Packaging validation protocol (IS… T046 Packaging validation protocol (ISO 11607) class: package_validation (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-10 → 2026-03-18 P50 2026-03-20 · P80 2026-03-20 · P95 2026-03-20 last check-in: 2026-03-16 by Packaging Engineer Accelerated aging to 12-month she… T047 Accelerated aging to 12-month shelf life (ASTM F1980) class: accelerated_aging (rule) prior source: TODO(founder): ASTM F1980 arithmetic at the claimed shelf life and Q10; placeholder status: not_started 0% baseline 2026-04-14 → 2026-06-03 P50 2026-08-03 · P80 2026-09-06 · P95 2026-10-18 last check-in: none Package integrity and distributio… T048 Package integrity and distribution testing (ASTM D4169) class: package_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-06-03 → 2026-06-28 P50 2026-09-03 · P80 2026-10-09 · P95 2026-11-25 last check-in: none Sterilization and shelf-life summ… T049 Sterilization and shelf-life summary report class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: not_started 0% baseline 2026-07-03 → 2026-07-11 P50 2026-10-07 · P80 2026-11-18 · P95 2027-01-13 last check-in: none Sterilization and aging complete baseline 2026-07-11 M5 Sterilization and aging complete class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: not_started 0% baseline 2026-07-11 → 2026-07-11 P50 2026-10-07 · P80 2026-11-18 · P95 2027-01-13 last check-in: none P80 2026-11-18 · BLOCKED Design verification master plan T050 Design verification master plan class: dv_execution (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-28 → 2026-03-08 P50 2026-03-08 · P80 2026-03-08 · P95 2026-03-08 last check-in: 2026-03-09 by Test Engineer DV protocol: dimensional and visu… T051 DV protocol: dimensional and visual class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-14 P50 2026-03-16 · P80 2026-03-16 · P95 2026-03-16 last check-in: 2026-03-16 by Test Engineer DV protocol: balloon burst and co… T052 DV protocol: balloon burst and compliance class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-16 P50 2026-03-16 · P80 2026-03-16 · P95 2026-03-16 last check-in: 2026-03-09 by Test Engineer DV protocol: fatigue and inflatio… T053 DV protocol: fatigue and inflation cycles class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-16 P50 2026-03-15 · P80 2026-03-15 · P95 2026-03-15 last check-in: 2026-03-16 by Test Engineer DV protocol: tensile and bond str… T054 DV protocol: tensile and bond strength class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-14 P50 2026-03-13 · P80 2026-03-13 · P95 2026-03-13 last check-in: 2026-03-16 by Test Engineer DV protocol: trackability and pus… T055 DV protocol: trackability and pushability class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-15 P50 2026-03-16 · P80 2026-03-16 · P95 2026-03-16 last check-in: 2026-03-16 by Test Engineer DV protocol: torque and kink resi… T056 DV protocol: torque and kink resistance class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-14 P50 2026-03-15 · P80 2026-03-15 · P95 2026-03-15 last check-in: 2026-03-16 by Test Engineer DV protocol: coating integrity an… T057 DV protocol: coating integrity and particulates class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-08 → 2026-03-17 P50 2026-03-19 · P80 2026-03-19 · P95 2026-03-19 last check-in: 2026-03-16 by Test Engineer DV protocol approval cycle T058 DV protocol approval cycle class: dv_protocol_approval (rule) prior source: TODO(founder): placeholder status: in_progress 60% baseline 2026-03-17 → 2026-03-27 P50 2026-04-04 · P80 2026-04-07 · P95 2026-04-12 last check-in: 2026-03-23 by Quality Engineer Test method validation: burst fix… T059 Test method validation: burst fixture class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: in_progress 95% baseline 2026-03-16 → 2026-03-28 P50 2026-03-31 · P80 2026-03-31 · P95 2026-03-31 last check-in: 2026-03-30 by Test Engineer Test method validation: fatigue f… T060 Test method validation: fatigue fixture class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: in_progress 95% baseline 2026-03-16 → 2026-03-28 P50 2026-03-31 · P80 2026-03-31 · P95 2026-03-31 last check-in: 2026-03-30 by Test Engineer DV execution: dimensional and vis… T061 DV execution: dimensional and visual class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-04-25 P50 2026-06-21 · P80 2026-07-14 · P95 2026-08-13 last check-in: none DV execution: balloon burst and c… T062 DV execution: balloon burst and compliance class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-05-01 P50 2026-06-29 · P80 2026-07-23 · P95 2026-08-23 last check-in: none DV execution: fatigue and inflati… T063 DV execution: fatigue and inflation cycles class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-05-09 P50 2026-07-10 · P80 2026-08-05 · P95 2026-09-08 last check-in: none DV execution: tensile and bond st… T064 DV execution: tensile and bond strength class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-04-27 P50 2026-06-24 · P80 2026-07-16 · P95 2026-08-16 last check-in: none DV execution: trackability and pu… T065 DV execution: trackability and pushability class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-04-29 P50 2026-06-26 · P80 2026-07-19 · P95 2026-08-18 last check-in: none DV execution: torque and kink res… T066 DV execution: torque and kink resistance class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-04-27 P50 2026-06-24 · P80 2026-07-17 · P95 2026-08-15 last check-in: none DV execution: coating integrity a… T067 DV execution: coating integrity and particulates class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-05-04 P50 2026-07-03 · P80 2026-07-28 · P95 2026-08-28 last check-in: none Simulated-use bench model qualifi… T068 Simulated-use bench model qualification class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-28 → 2026-03-15 P50 2026-03-15 · P80 2026-03-15 · P95 2026-03-15 last check-in: 2026-03-16 by Test Engineer DV execution: simulated use in be… T069 DV execution: simulated use in bench model class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-05-01 P50 2026-06-29 · P80 2026-07-23 · P95 2026-08-21 last check-in: none Design verification report T070 Design verification report class: dv_execution (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-05-09 → 2026-05-21 P50 2026-08-03 · P80 2026-08-30 · P95 2026-10-05 last check-in: none Design verification complete baseline 2026-05-21 M6 Design verification complete class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: not_started 0% baseline 2026-05-21 → 2026-05-21 P50 2026-08-03 · P80 2026-08-30 · P95 2026-10-05 last check-in: none P80 2026-08-30 · BLOCKED Use specification and use-related… T071 Use specification and use-related risk analysis class: risk_management_file (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-01-27 → 2026-02-06 P50 2026-02-09 · P80 2026-02-09 · P95 2026-02-09 last check-in: 2026-02-02 by Clinical Lead Formative usability evaluation T072 Formative usability evaluation class: usability_validation_62366 (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-13 → 2026-02-25 P50 2026-02-26 · P80 2026-02-26 · P95 2026-02-26 last check-in: 2026-02-23 by Clinical Lead IFU draft T073 IFU draft class: labeling_ifu (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-25 → 2026-03-07 P50 2026-03-06 · P80 2026-03-06 · P95 2026-03-06 last check-in: 2026-03-09 by Regulatory Lead Labelling and artwork (UDI) T074 Labelling and artwork (UDI) class: labeling_ifu (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-03-10 → 2026-03-22 P50 2026-03-22 · P80 2026-03-22 · P95 2026-03-22 last check-in: 2026-03-16 by Regulatory Lead Summative usability validation (I… T075 Summative usability validation (IEC 62366-1) class: usability_validation_62366 (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-05-09 P50 2026-07-10 · P80 2026-08-05 · P95 2026-09-08 last check-in: none Design validation: simulated clin… T076 Design validation: simulated clinical use class: design_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-05-09 → 2026-05-29 P50 2026-08-08 · P80 2026-09-07 · P95 2026-10-16 last check-in: none Design validation report T077 Design validation report class: design_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-05-29 → 2026-06-06 P50 2026-08-19 · P80 2026-09-19 · P95 2026-10-28 last check-in: none Risk management report (ISO 14971) T078 Risk management report (ISO 14971) class: risk_management_file (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-06-06 → 2026-06-14 P50 2026-09-03 · P80 2026-10-04 · P95 2026-11-13 last check-in: none Process validation plan T079 Process validation plan class: process_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-04-27 P50 2026-06-24 · P80 2026-07-16 · P95 2026-08-16 last check-in: none IQ: assembly and bonding equipment T080 IQ: assembly and bonding equipment class: process_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-27 → 2026-05-07 P50 2026-07-08 · P80 2026-07-31 · P95 2026-08-31 last check-in: none OQ: bonding process T081 OQ: bonding process class: process_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-05-07 → 2026-05-22 P50 2026-07-28 · P80 2026-08-23 · P95 2026-09-25 last check-in: none PQ: three confirmation lots T082 PQ: three confirmation lots class: process_validation (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-05-22 → 2026-06-11 P50 2026-08-23 · P80 2026-09-22 · P95 2026-10-30 last check-in: none Device master record compilation T083 Device master record compilation class: design_transfer (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-06-11 → 2026-06-21 P50 2026-09-05 · P80 2026-10-07 · P95 2026-11-14 last check-in: none Design transfer review T084 Design transfer review class: design_transfer (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-06-21 → 2026-06-26 P50 2026-09-12 · P80 2026-10-14 · P95 2026-11-21 last check-in: none Predicate comparison and SE ratio… T085 Predicate comparison and SE rationale class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-28 → 2026-03-12 P50 2026-03-12 · P80 2026-03-12 · P95 2026-03-12 last check-in: 2026-03-09 by Regulatory Lead 510(k) sections: device descripti… T086 510(k) sections: device description and labelling class: labeling_ifu (rule) prior source: TODO(founder): placeholder status: in_progress 10% baseline 2026-03-22 → 2026-04-01 P50 2026-04-09 · P80 2026-04-15 · P95 2026-04-26 last check-in: 2026-03-23 by Regulatory Lead 510(k) sections: performance test… T087 510(k) sections: performance testing summaries class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-07-11 → 2026-07-26 P50 2026-10-23 · P80 2026-12-04 · P95 2027-01-28 last check-in: none 510(k) sections: sterilization, s… T088 510(k) sections: sterilization, shelf life, biocomp class: biocomp_iso10993_panel (rule) prior source: TODO(founder): lab published lead times + FDA 2023 guidance; placeholder status: not_started 0% baseline 2026-07-11 → 2026-07-19 P50 2026-10-17 · P80 2026-11-28 · P95 2027-01-22 last check-in: none eSTAR assembly and RTA self-check T089 eSTAR assembly and RTA self-check class: regulatory_submission_assembly (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-07-26 → 2026-08-05 P50 2026-11-09 · P80 2026-12-22 · P95 2027-02-14 last check-in: none Submission quality review and sig… T090 Submission quality review and sign-off class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-08-05 → 2026-08-10 P50 2026-11-14 · P80 2026-12-27 · P95 2027-02-19 last check-in: none 510(k) submission to FDA T091 510(k) submission to FDA class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-08-10 → 2026-08-12 P50 2026-11-16 · P80 2026-12-29 · P95 2027-02-21 last check-in: none 510(k) submitted baseline 2026-08-12 M7 510(k) submitted class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: not_started 0% baseline 2026-08-12 → 2026-08-12 P50 2026-11-16 · P80 2026-12-29 · P95 2027-02-21 last check-in: none P80 2026-12-29 · BLOCKED FDA 510(k) review to decision T092 FDA 510(k) review to decision class: fda_510k_review (rule) prior source: openFDA 510(k) endpoint via the Clearance Timeline Estimator pipeline; snapshot generated 2026-08-29 (openFDA last_updated 2026-08-17); decisions 2018-01-01 to 2026-08-28; pooled histogram of days from receipt to decision over n=24,912 cleared records in 742 product codes with >= 5 records; 20-day bins, 0 records in the open tail beyond 1360 days status: not_started 0% baseline 2026-08-12 → 2027-01-09 P50 2027-04-06 · P80 2027-08-14 · P95 2028-04-20 last check-in: none 510(k) cleared baseline 2027-01-09 M8 510(k) cleared class: milestone (rule) prior source: Structural; a milestone has no duration of its own status: not_started 0% baseline 2027-01-09 → 2027-01-09 P50 2027-04-06 · P80 2027-08-14 · P95 2028-04-20 last check-in: none P80 2027-08-14 · BLOCKED Marker band swaging process devel… T093 Marker band swaging process development class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-05 → 2026-02-13 P50 2026-02-14 · P80 2026-02-14 · P95 2026-02-14 last check-in: 2026-02-09 by Manufacturing Engineer Hydrophilic coating process devel… T094 Hydrophilic coating process development class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-05 → 2026-02-20 P50 2026-02-23 · P80 2026-02-23 · P95 2026-02-23 last check-in: 2026-02-16 by R&D Lead Coating supplier evaluation T095 Coating supplier evaluation class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-20 → 2026-03-02 P50 2026-02-28 · P80 2026-02-28 · P95 2026-02-28 last check-in: 2026-03-02 by Supplier Quality Balloon fold and wrap process dev… T096 Balloon fold and wrap process development class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-13 → 2026-02-25 P50 2026-02-28 · P80 2026-02-28 · P95 2026-02-28 last check-in: 2026-02-23 by Manufacturing Engineer Bond joint design of experiments T097 Bond joint design of experiments class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-13 → 2026-02-27 P50 2026-02-28 · P80 2026-02-28 · P95 2026-02-28 last check-in: 2026-02-23 by R&D Lead Shaft stiffness characterisation T098 Shaft stiffness characterisation class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-13 → 2026-02-19 P50 2026-02-18 · P80 2026-02-18 · P95 2026-02-18 last check-in: 2026-02-16 by Test Engineer Guidewire compatibility check T099 Guidewire compatibility check class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-13 → 2026-02-17 P50 2026-02-19 · P80 2026-02-19 · P95 2026-02-19 last check-in: 2026-02-16 by Test Engineer Traceability matrix (requirements… T100 Traceability matrix (requirements to tests) class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-03-08 → 2026-03-16 P50 2026-03-16 · P80 2026-03-16 · P95 2026-03-16 last check-in: 2026-03-09 by Quality Engineer Design history file index T101 Design history file index class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-27 → 2026-02-01 P50 2026-02-03 · P80 2026-02-03 · P95 2026-02-03 last check-in: 2026-02-02 by Quality Engineer Supplier audit: balloon supplier T102 Supplier audit: balloon supplier class: supplier_fai (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-02-20 → 2026-02-26 P50 2026-02-27 · P80 2026-02-27 · P95 2026-02-27 last check-in: 2026-02-23 by Supplier Quality Cleanroom gowning and flow proced… T103 Cleanroom gowning and flow procedure class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-03-17 → 2026-03-22 P50 2026-03-22 · P80 2026-03-22 · P95 2026-03-22 last check-in: 2026-03-23 by Manufacturing Engineer Bioburden baseline sampling T104 Bioburden baseline sampling class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: not_started 0% baseline 2026-04-14 → 2026-04-24 P50 2026-06-19 · P80 2026-07-11 · P95 2026-08-11 last check-in: none Endotoxin (LAL) testing T105 Endotoxin (LAL) testing class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-04-14 → 2026-04-26 P50 2026-06-19 · P80 2026-07-10 · P95 2026-08-09 last check-in: none Particulate baseline testing T106 Particulate baseline testing class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-04-14 → 2026-04-22 P50 2026-06-15 · P80 2026-07-06 · P95 2026-08-04 last check-in: none Complaint handling procedure upda… T107 Complaint handling procedure update class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-27 → 2026-02-01 P50 2026-02-01 · P80 2026-02-01 · P95 2026-02-01 last check-in: 2026-02-02 by Quality Engineer Post-market surveillance plan T108 Post-market surveillance plan class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-06-14 → 2026-06-20 P50 2026-09-10 · P80 2026-10-11 · P95 2026-11-19 last check-in: none Clinical evaluation memo (literat… T109 Clinical evaluation memo (literature) class: design_validation (rule) prior source: TODO(founder): placeholder status: done 100% baseline 2026-01-25 → 2026-02-06 P50 2026-02-04 · P80 2026-02-04 · P95 2026-02-04 last check-in: 2026-02-02 by Clinical Lead Competitive device teardown T110 Competitive device teardown class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-16 → 2026-01-24 P50 2026-01-24 · P80 2026-01-24 · P95 2026-01-24 last check-in: 2026-01-26 by R&D Lead Cost model and margin review T111 Cost model and margin review class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-08 → 2026-02-14 P50 2026-02-12 · P80 2026-02-12 · P95 2026-02-12 last check-in: 2026-02-16 by Program Manager Program schedule re-baseline revi… T112 Program schedule re-baseline review class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-02-28 → 2026-03-03 P50 2026-03-06 · P80 2026-03-06 · P95 2026-03-06 last check-in: 2026-03-02 by Program Manager Pilot lot P2 build (validation un… T113 Pilot lot P2 build (validation units) class: pilot_build (rule) prior source: TODO(founder): placeholder status: not_started 0% baseline 2026-04-19 → 2026-04-29 P50 2026-06-27 · P80 2026-07-20 · P95 2026-08-20 last check-in: none Sterile barrier seal validation T114 Sterile barrier seal validation class: sterilization_validation (rule) prior source: TODO(founder): contract steriliser published lead times; placeholder status: in_progress 80% baseline 2026-03-18 → 2026-04-02 P50 2026-04-02 · P80 2026-04-04 · P95 2026-04-07 last check-in: 2026-03-30 by Packaging Engineer Shipping carton design T115 Shipping carton design class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-03-10 → 2026-03-16 P50 2026-03-16 · P80 2026-03-16 · P95 2026-03-16 last check-in: 2026-03-16 by Packaging Engineer Label printer qualification T116 Label printer qualification class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-03-22 → 2026-03-27 P50 2026-03-27 · P80 2026-03-27 · P95 2026-03-27 last check-in: 2026-03-23 by Manufacturing Engineer Software: inflation device compat… T117 Software: inflation device compatibility note class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-01-20 → 2026-01-24 P50 2026-01-25 · P80 2026-01-25 · P95 2026-01-25 last check-in: 2026-01-26 by Software Lead Training material for field T118 Training material for field class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: done 100% baseline 2026-03-07 → 2026-03-15 P50 2026-03-16 · P80 2026-03-16 · P95 2026-03-16 last check-in: 2026-03-16 by Clinical Lead Launch readiness checklist draft T119 Launch readiness checklist draft class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-06-26 → 2026-07-01 P50 2026-09-18 · P80 2026-10-19 · P95 2026-11-27 last check-in: none Lessons-learned review T120 Lessons-learned review class: generic_task (default) prior source: Plan baseline duration; spread is the library default `generic_sigma`, a labelled design default, not a measurement status: not_started 0% baseline 2026-08-12 → 2026-08-15 P50 2026-11-19 · P80 2027-01-01 · P95 2027-02-24 last check-in: none

Source: Cadence MD engine 0.1.0, forecast.json run 20260330T120000Z-1a944fef, engine 0.1.0, library 0.1; 10,000 Monte Carlo runs, seed 42, as of 2026-03-30; 128 tasks, 0 dependency references excluded. Calibration: n_resolved=0 — unsourced reference classes in use: accelerated_aging, biocomp_iso10993_panel, design_freeze, design_input_review, design_review_gate, design_transfer, design_validation, dv_execution, dv_protocol_approval, labeling_ifu, package_validation, pilot_build, presub_qsub, process_validation, regulatory_submission_assembly, risk_management_file, sterilization_validation, supplier_fai, tooling_lead_time, usability_validation_62366., retrieved 2026-03-30. n=128. Unsourced reference classes in use: 20. Their durations are placeholders marked TODO in the library, which is why the badge reads CALIBRATION: SYNTHETIC.

Limited intake

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The Thursday-night slide, generated instead of rebuilt

In most device programs the true state lives in four places, a phase-gate record, a task tracker, a test lab's queue and a supplier's purchase order, and reaches leadership as a slide somebody rebuilt by hand. Cadence MD reads the plan, keeps a probabilistic forecast of every milestone, and drafts the update into the organisation's own template. The draft is not a report until a named program manager has dispositioned every change in it.

Dates come from the engine. A language model may classify, parse and write prose. It may not set a date, and the run log proves it did not.

Run it in ninety seconds

Python 3.11 or newer; nothing else to install. From a checkout of this repository:

py -3 -m cadence demo run

That builds the synthetic program you see above, applies twelve weeks of check-ins, runs 10,000 Monte Carlo iterations in a few seconds and writes forecast.json and a self-contained gantt.html. For your own plan:

py -3 -m cadence init ./programs/my-program --id P-001 --name "My program" --start 2026-01-05
py -3 -m cadence run ./programs/my-program

Drop a plan beside program.json: a CSV in the documented schema, an MS Project XML, or a Jira or Azure DevOps CSV export. cadence validate shows how every row was read and classified before anything runs.

Wire it to your agent

The engine is also an MCP server over stdio, which is the one interface Claude Code, Claude Desktop, GitHub Copilot in VS Code, Cursor, Windsurf and Codex all speak. One command writes the config:

py -3 -m cadence agents install ./programs/my-program --for claude-code
py -3 -m cadence agents install ./programs/my-program --for vscode
py -3 -m cadence agents install ./programs/my-program --for cursor

Or by hand. Claude Code and Cursor (.mcp.json / .cursor/mcp.json):

{
  "mcpServers": {
    "cadence": {
      "command": "py",
      "args": ["-3", "-m", "cadence", "mcp", "--program", "./programs/my-program"]
    }
  }
}

GitHub Copilot in VS Code (.vscode/mcp.json):

{
  "servers": {
    "cadence": {
      "type": "stdio",
      "command": "py",
      "args": ["-3", "-m", "cadence", "mcp", "--program", "./programs/my-program"]
    }
  }
}

The server sends the agent its rules in the handshake, and the repository ships them as a Claude skill and a generic AGENTS.md: quote the field a date came from, say "Not in the plan" when the data cannot answer, ask the human for their own name before recording a disposition, never work around the export gate, never write to a tracker. The last two are not requests: the server has no tool that could do either.

The reference library, and where its numbers come from

Every task is classified into a reference class, a recurring kind of device-program activity with a duration distribution, a rework probability and a source. The library ships as a versioned YAML file. A class whose source still reads TODO is unsourced: the engine refuses to run against it unless told to, and then badges every output. In this release the placeholders outnumber the sourced entries, and the page says so rather than hiding it.

The one computed class is the FDA 510(k) review clock. It is read off the pooled openFDA snapshot behind the Clearance Timeline Estimator, and its source line carries the snapshot date, the decision window, the record count and the bin width. A 10xAnd-operated MCP endpoint serves the same library and, per product code, that code's own receipt-to-decision percentiles, so a program can pull real public data for its pathway:

py -3 -m cadence library sync ./programs/my-program --url https://10xand.com/mcp/cadence --product-code DQY

The endpoint receives a product code at most. It never sees a plan, a task name or a check-in.

What the numbers are

FigureHow it is computed
BaselineYour plan's finish date for the milestone, or the critical-path finish from your start date and durations if the plan carries none.
P50 / P80 / P95The date by which the milestone finished in 50%, 80% and 95% of the seeded Monte Carlo runs. Each run draws every open task's duration from its class distribution around the plan's baseline, adds rework by the class probability, and walks the dependency graph.
P(on baseline)The share of runs that finished on or before the baseline.
StateREADY if P80 is on or before baseline; ATTENTION if P80 is late by less than a tenth of the time remaining; BLOCKED otherwise.
Top driverAmong the open tasks on the milestone's driving path, the one whose elapsed time correlates most strongly with the milestone finish across runs, with the share of late runs it sat on the path.
CalibrationBrier score on P(on baseline), 80% interval coverage and mean absolute error by class, over every forecast made before a milestone resolved. With nothing resolved there is nothing to claim, and the badge says so.

What it will not do

  • Write to your tracker. Jira, Azure DevOps, MS Project, Planner, Smartsheet and PLM are read from exports and never written. Plan changes come out as worklists.
  • Publish without a name. Export and any channel post are blocked until every forecast change since the last report has a disposition from a human who typed their own name.
  • Claim a track record. Nothing about forecast quality is stated anywhere the calibration ledger does not show it. The first published ledger will be computed on a real program, not asserted.
  • Send your plan anywhere. No hosted service holds program data. The engine's only outbound calls are the library sync you run and an inference endpoint you configure, both logged in the run log.

Questions we get

Where does my plan go when I use Cadence MD?

Nowhere. The engine is a Python package that runs on your machine and writes only into the program directory you point it at. The MCP server is a local subprocess your agent starts. The only network call the free tier can make is the library sync you run yourself, which downloads reference data and uploads nothing but, optionally, a product code. The viewer on this page reads a forecast.json in your browser with FileReader and makes no request.

What is a reference class, and why does the badge say CALIBRATION: SYNTHETIC?

A reference class is a kind of activity that recurs in device programs — a biocompatibility panel, a sterilization validation, an FDA 510(k) review clock — with a duration distribution, a rework probability and a source for those numbers. The engine refuses to run against a class whose source is still marked TODO unless you pass --allow-unsourced, and then every output carries the badge. In this release most classes are placeholders awaiting authorship; the one exception is the 510(k) review clock, computed from the openFDA snapshot behind the Clearance Timeline Estimator, with n and the snapshot date in its source line. The badge also stays on until at least one milestone has resolved and the calibration ledger has something to show.

Does a language model set the dates?

No. Dates come from three deterministic layers: the critical-path method on the plan, the reference-class priors, and a seeded Monte Carlo. A configured model (off by default) may suggest a class for an unmatched task, parse a free-text check-in reply, and draft the executive summary prose. Every completion passes through the run log, which withholds any date-like string and counts how many it withheld; the count is in the run log of every run.

Why can I not export the status report straight away?

Because a forecast change is a claim, and a named human has to stand behind it before it leaves the tool. Every milestone whose P80 or state moved since the last exported report needs a disposition — accept, override with a reason, or defer with a reason — from a reviewer who gives their own name. The export carries the disposition record as an appendix. An override records the reviewer's date beside the engine's, never in place of it. Drafting is never gated.

Can it update Jira, Azure DevOps or MS Project?

No, permanently. The engine reads exports and never writes to a system of record. When a plan should change, it produces a worklist the program manager applies themselves. The MCP server exposes no tool that could write, so an agent cannot be talked into it.

What does P80 mean here, and how should I read the lamp?

P80 is the date by which the milestone finished in 80% of the Monte Carlo runs. The lamp follows fixed thresholds: READY when P80 is on or before the baseline; ATTENTION when P80 is late by less than a tenth of the time remaining to the baseline; BLOCKED when it is later than that. The thresholds live in program.json. Nothing about the lamp is a judgement of anyone's work; it is arithmetic on the plan and the priors.

What is the difference between the free tier and Cadence for Teams?

Same engine. The free tier is the local CLI, the MCP server and the HTML Gantt, with a file-based check-in loop. Cadence for Teams is the same engine deployed as a container inside an organisation's own Microsoft 365 tenant, surfaced as a Teams app with read-only connectors and the check-in loop in chat, sold as a deployment plus a calibration engagement. It is not built yet and this page makes no claim about it beyond that sentence. "for Microsoft Teams" and "for Jira" describe compatibility; Cadence MD is not affiliated with Microsoft or Atlassian.