R&Q Resources

EU | This is where you'll find our webinars, events, and more.

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EU MDR: Assessing the Impact and Next Steps [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held..


Japan PMDA, EU, audits, TGA, GHTF, FDA, health canada, quality improvements, iso 13485

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..

listing, MDD, EU, Medical Devices, us, gmp, mdufa III, FDA, FDASIA, enforcement actions, registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:

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..

MDD, EU, label, Regulatory Affairs, RQS, labeling, ifu, FDA, health canada, medical device, user guide, instructions for use, manual

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..