AI Development & Lifecycle Plan (AI-01)
Master lifecycle plan integrating IEC 62304 software lifecycle, the IMDRF GMLP principles and the Health Canada 9-stage ML lifecycle. Sets the framework all other AI documents reference.
AI/ML Medical Device Documentation Hub
AI/ML Medical Device Documentation
The deliverable documentation kit for AI/ML-enabled medical devices — one coordinated set, five markets. Covers the full lifecycle, from AI Development & Lifecycle Plan to Postmarket Performance Monitoring, with the IMDRF Good Machine Learning Practice principles as the convergent spine across FDA, EU AI Act, Health Canada, TGA and ANVISA. Or buy only the document you need.
10 coordinated documents
5 jurisdictions, one kit
GMLP-aligned spine
Instant download
MD Regulatory
AI/ML
Medical Device Documentation Kit
10 coordinated documents
Plans · Reports · PCCP · SOP
FDA · EU AI Act · HC · TGA · ANVISA
+ README & Master Index (Excel)
Instant download after purchase
Complete Bundle
AI/ML Medical Device Documentation Kit
Everything you need to build a defensible AI/ML technical file across five regulatory markets. 10 professionally drafted documents covering the AI lifecycle plan, data governance & bias management, model validation, AI risk management, the Predetermined Change Control Plan (PCCP), human oversight & transparency, postmarket performance monitoring, the AI-augmented Clinical Evaluation Plan & Report, and the AI/ML development SOP — all built on a deep, multi-jurisdictional standard with the IMDRF GMLP principles as the convergent spine. Includes a README user guide and a 5-sheet Master Index & Conformity Matrix (Excel), bundle-only.
9 Word + Master Index (Excel)
PCCP — FDA + HC nomenclature
IMDRF GMLP (10 principles)
EU AI Act Art. 13–14
ISO 14971 + AAMI CR34971
IEC 62304 + ISO 13485 §7.5
€499
one-time payment · lifetime access
⚡ Save ~28% vs buying documents individually (€690 → €499)
Or buy only the document you need
Each document is professionally drafted, fully editable, and built from public primary sources (FDA, IMDRF, Health Canada, EU AI Act, ISO 13485 §7.5).
Filter by document type or jurisdiction focus:
Document Type
Jurisdiction Focus
Data Governance & Bias Management Plan (AI-02)
Data sourcing, representativeness, dataset independence and bias identification & mitigation across the lifecycle. The depth-pilot document — the density benchmark for the whole kit.
Model Validation & Performance Report (AI-03)
Standalone performance evaluation plus subgroup / sub-population performance analysis, with the methodology and acceptance criteria expected by reviewers across all five markets.
AI Risk Management Plan & Report (AI-04)
ISO 14971 risk management extended with AAMI CR34971 guidance on AI/ML-specific hazards — data drift, automation bias, generalisation failure and more.
Predetermined Change Control Plan (AI-05)
The PCCP — the kit's flagship. Defines pre-authorised modifications, the modification protocol and impact assessment, aligned with FDA and Health Canada PCCP nomenclature so a single plan serves multiple markets.
Human Oversight & Transparency Plan (AI-06)
GMLP principles P7/P9 plus the Transparency guiding principles and EU AI Act Articles 13–14 on transparency and human oversight, in one coordinated plan.
Postmarket AI Performance Monitoring (AI-07)
Real-world performance monitoring: drift detection, logging strategy and re-training triggers, structured to feed back into the PCCP and the risk file.
Clinical Evaluation Plan — AI-Augmented (AI-08a)
A clinical evaluation plan built on a real CEP template, with AI-specific additions clearly flagged as [AI MODULE] so the AI evidence strategy integrates with your existing clinical process.
Clinical Evaluation Report — AI-Augmented (AI-08b)
The reporting counterpart to AI-08a, built on a real CER template with [AI MODULE] markers, documenting the AI clinical evidence and its benefit-risk contribution.
SOP — AI/ML Model Development & Lifecycle (AI-09)
The procedural SOP your ISO 13485 QMS requires: roles, steps and stage gates for AI/ML model development, built from public ISO 13485 §7.5 and the GMLP process structure.
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One kit, five markets — GMLP as the spine
Each document is mapped to its primary reference and the convergent IMDRF GMLP principles, so a single coordinated set serves FDA, EU AI Act, Health Canada, TGA and ANVISA.
| Document | Primary Reference | Convergent Spine | When to produce |
|---|---|---|---|
| AI-01 | IEC 62304 + HC 9-stage | IMDRF GMLP (all) | Project start, before design input |
| AI-02 | GMLP P1–P3 (data) | IMDRF GMLP (all) | Data strategy phase |
| AI-03 | GMLP P5–P6 (eval) | IMDRF GMLP (all) | Model validation phase |
| AI-04 | ISO 14971 + AAMI CR34971 | IMDRF GMLP (all) | Early, refined ongoing |
| AI-05 (PCCP) | FDA + HC PCCP guidance | IMDRF GMLP P10 | Before submission, maintained |
| AI-06 | EU AI Act Art. 13–14 | GMLP P7/P9 + Transparency GP | Design + labelling phase |
| AI-07 | GMLP P9–P10 (monitoring) | IMDRF GMLP (all) | Pre-launch, run continuously |
| AI-08a / 08b | MDR Art. 61 + [AI MODULE] | GMLP clinical principles | Before NB submission |
| AI-09 (SOP) | ISO 13485 §7.5 | GMLP process structure | QMS implementation |
Frequently Asked Questions
Are these documents ready to submit to a regulator or Notified Body?
The documents provide the complete structure, methodology and required content sections expected across the five covered markets. You must populate them with your device-specific data, model details, performance results and benefit-risk analysis, and have the expert-judgment points validated. They are professional, deep starting points — roughly 75–80% deliverable — not a substitute for AI/ML regulatory and clinical expertise.
Which markets does the kit cover?
FDA (US), the EU AI Act and MDR, Health Canada, Australia's TGA and Brazil's ANVISA. The IMDRF Good Machine Learning Practice principles are used as the convergent spine, so a single coordinated set is structured to serve all five rather than maintaining five separate files.
What is the PCCP and why is it highlighted?
The Predetermined Change Control Plan (AI-05) is the kit's flagship document. It defines in advance which model modifications are pre-authorised, the modification protocol and the impact assessment — aligned with both FDA and Health Canada PCCP nomenclature so one plan can support multiple markets. It is the document most often cited as the hardest to draft from scratch for AI/ML devices.
How does this kit relate to the Cybersecurity Kit?
They are separate, complementary products. AI/ML-enabled devices typically also need a medical device cybersecurity file; the AI kit cross-references the Cybersecurity Kit as a companion but is sold independently and stands on its own.
What format are the files in, and what's in the bundle only?
Nine editable Word .docx documents (AI-01 to AI-09, with AI-08 split into 08a and 08b). The complete bundle additionally includes a README user guide and a 5-sheet Master Index & Conformity Matrix in Excel (kit index plus GMLP, Transparency, Regulatory and Jurisdiction matrices) — these two are bundle-only and not sold separately.
How were the documents written — are competitor templates involved?
No. All content is built from public primary sources — FDA, IMDRF GMLP, Health Canada, the EU AI Act and ISO 13485 §7.5 — verified through research during development. Competitor or non-commercially-licensed materials were never copied; they were used at most as a completeness reference.
How do I get updates if guidance changes?
You receive lifetime access. As FDA, IMDRF, Health Canada or EU AI Act guidance evolves, registered customers receive update notifications by email with revised documents at no additional cost.
Is the kit licensed for use across multiple devices?
Yes — licensed for internal use within your organisation across multiple device families and projects. Internal team members can use and adapt the documents. Redistribution outside your organisation or reselling is not permitted.
Do you offer consulting on top of these documents?
Yes. For the device-specific completion and expert-judgment validation — PCCP scoping, subgroup performance strategy, AI risk facilitation, submission preparation — we offer dedicated consulting. Contact us through the consulting page.