Curriculum traceability
iso_13485
This matrix shows how each curriculum area maps to iso_13485requirements — the clause or control it supports, how it's taught, and the evidence the learner and organisation receive. It's a sample, illustrative mapping; your live records (completions, assessment scores, version history) form the per-organisation evidence pack.
What this supports — and what it doesn't
These programs support preparation for iso_13485 certification: they deliver the awareness and competence training the standard requires (notably Clause 7.2 Competence, 7.3 Awareness, and Annex A 6.3) and produce the documented completion and assessment records auditors look for. They do notby themselves certify your organisation or any individual, and they don't guarantee certification — your organisation still implements the management system and is audited by an accredited certification body. Training is the supporting evidence, not the certificate.
Medical Device Quality & Risk (ISO 13485 + 14971)
| Curriculum area | iso_13485 clauses / controls | Method | Evidence produced |
|---|---|---|---|
| 13485 Foundations & Regulatory Landscape | Clause 4-5Clause 4.2 | Lesson + knowledge-check | Per-learner completion + assessment score |
| Design Controls (DHF/DMR/DHR) | Clause 7.3 | Lesson + knowledge-check | Per-learner completion + assessment score |
| Production, Suppliers & CAPA | Clause 7.4Clause 7.5Clause 8.5 | Lesson + knowledge-check | Per-learner completion + assessment score |
| Post-Market Surveillance, Vigilance & SaMD | Clause 7.3.10Clause 8.2.2Clause 8.5 | Lesson + knowledge-check | Per-learner completion + assessment score |
| Whole program — medical-device QMS competence | Clause 6.2Clause 7.3.2 | Lessons + quizzes + capstone | Per-learner completion + assessment score |
Hover a clause code for its title. Clause references follow iso_13485. For a per-organisation, audit-ready evidence pack, get in touch.