Curriculum traceability
ISO 14971 (Medical Device Risk Management)
This matrix shows how each curriculum area maps to ISO 14971 (Medical Device Risk Management)requirements — 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 14971 (Medical Device Risk Management) 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 clauses / controls | Method | Evidence produced |
|---|---|---|---|
| Risk Management Lifecycle | Clause 4-9 | Lesson + knowledge-check | Per-learner completion + assessment score |
Hover a clause code for its title. Clause references follow ISO 14971 (Medical Device Risk Management). For a per-organisation, audit-ready evidence pack, get in touch.