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I'm looking for recommendations on which certification and/or professional association would be best for strengthening my skills in auditing, statistical process control, and general quality and compliance issues. Any thoughts? ASQ? RAPS? CMQ/OE? Six...
The example provided in the Practical Guide for the implementation of a “risk-based approach” contains a single, one-paragraph example outlines three steps:• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an in...
I have just released the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” This post explores insights from the Practical Guide on “risk-based approach,” the varying terminology used to reference it, and the QMS p...
Hello, I am working in local medical device importing company. I'd like to listen to your experience and opinion about Application of ISO14971 to the Sales site independently. We are not a manufacturer and there are no local regulation or obligation ...
Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague ...
Just after Halloween, the FDA issued a Consent Decree to Philips Healthcare for a number of egregious violations involving their external defibrillators. Philips had “tricked” industry by consistently providing unsafe defibrillators so the FDA “treat...
Did you know that every year since 2010 the #1 reason medical device companies receive FDA 483's is poor CAPA procedures? Here's a best practice guide to help you implement a best practice approach to CAPA while avoiding the common pitfalls → https:/...
Hi everybody! Can someone tell the difference between the sentences: 1- " shall document a procedure" and 2- "shall document procedures"? Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 ...
Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
Presentation at the Personal Connected Health Alliance about regulatory trends in EU regulation of software as medical device in Vienna, May 2017Trends in EU regulation of software as medical devicePresentation at the Personal Connected Health Allian...
