Medical Device File Requirements (ISO 13485 Cl. 4.2.3)

[Philip B]

Really ... that's cool

They (BSi) recently announced that clients' next audit will be against 2016 regardless as they were concerned by the slow progress in uptake of 2016 and therefore are forcing the issue. But, sensibly, they have said there will be no major NCs raised on the first 2016 audit. Our next visit is in November and is an upgrade audit as we have recently opened a new cleanroom having previously outsourced our product manufacture. So the audit is the first for our new cleanroom and the first against 2016 - which will be interesting!

 

[Jane's]

We have been audited according to 13485:2016 last week, and the "medical device file" was not a problem. We have SOPs for the country-specific documentation requirements ("development of device master record" for the USA, "development of technical file" for EU), and in our quality manual we have added a chapter "medical device file" and just reference the SOPs. For our NB that was ok.

Likewise.