AAMI draft report - Postmarket Risk Management

Roland chung

Trusted Information Resource
So glad Elsmar Cove is back!

As we know, the post-production monitoring stated in ISO 14971 is also the subject of national regulations, where it is named as "post-market surveillance". I am wondering if they are exactly same.



I just wanted to Celebrate the Elsmar Cove RE-Opening. Where's a balloon or fireworks animation when you need one.

Elsmar seemed always to me to be the neutral territory for diverse discussions and a place to help with those most challenging technical issues, interpretations and practical implementations. Or just a place to blow of steam with others, or ill-felt burdens within our profession. Those matter too.,

Thank the creator and stewards of Elsmar Cove for carrying on this legacy, which has helped so many quality and regulatory professionals riding the steep hills of new regulations and standards, of which so many are now arriving.
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