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FDA’s Guidance Document on Voluntary Submission ...

I came across an FDA guidance document – not entirely recent; however, I found..

QMS, MDD, EU, Canada, Medical Devices, FDA, health canada, 21 cfr 820, Preventive Action, iso 13485

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word..

MDD, EU, FDA, health canada, medical device, cleveland

Mistake, I Think Not!

As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I..

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Labels impact the device

During this holiday season, when presents are being packaged and shipped at..

Biocompatibility, MDD, EU, Medical Devices, 10993-1, FDA, health canada, medical device, Medical Device Directive, 10993

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of..

MDD, EU, end user, FDA, health canada, medical device, customer

In Your Face

My teenager works at a local eatery – I thoroughly believe the saying, “A good..