How to structure an Essential Requirements checklist and traceability matrix for a UK MDR 2002 technical file — with a worked example framework, common pitfalls, and guidance on maintaining the checklist throughout the device lifecycle.
How to apply ISO 14971 risk management to satisfy Essential Requirement 2 of the UK MDR 2002 — the risk management plan, hazard identification, risk estimation, risk controls, residual risk evaluation, and the lifecycle requirement to keep the risk file updated.
What the technical file must contain under UK MDR 2002, how it is structured, the difference between a technical file and a design dossier, UKAB access requirements, and how the technical file must evolve throughout the device lifecycle.