MDSAP Audit Approach (MDSAP AU P0002) A1-techdoc: Maintain technical documentation (medical device file and design files) that evidences regulatory compliance, keep it current, and for Australia meet the minimum Essential Principles evidence set

What does A1-techdoc require?

The medical device file under ISO 13485:2016 clause 4.2.3 and the design and development files under 7.3.10 must contain or reference technical documentation showing compliance: design outputs, verification and validation data with acceptance criteria, the risk management file, human factors, software validation, clinical evaluation, electrical safety and EMC, production and QA specifications, packaging and labelling specifications and their validation, installation and servicing methods, and statements particular to a jurisdiction, such as a declaration of conformity. Arrangements must keep it current, for example reviewing the currency of standards, assessing changes for further testing, planning post-market clinical follow-up or literature review and updating risk documents from post-market data. Australia: the TGA expects review of a description (intended use, user, classification, GMDN code, and for IVDs specimen types, components and method), use of feedback in risk management, a document index, the risk management file, pre-clinical and bench reports, a current clinical evaluation report by a qualified expert, special requirements (medicinal substances, animal materials), the information supplied with the device including implant cards and leaflets, and the declaration of conformity; an Essential Principles checklist is optional but useful.