I agree with the prior comments with one caveat. I think the organization will be better off if you have your own staff immerse themselves in the 2016 standard, compare it side-by-side with the 2003 standard, and write your own prescription (Gap Analysis and Quality Plan) for your Quality Manual and procedure renovations. This is the responsibility ...

Hi Raja: On ISO 14971 the European Commission DG SANCO found conflict between the standard and Medical Device Directive some years ago. While this was based on a "letter" rather then "spirit of the law" interpretation there are philosophical pros and cons on many of the issues raised, for example:  - whether negligible risks should be eliminated ...

Dear colleagues, FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation". I understand that these are just words, but are these terms to FDA more of a claim that is intended ...