R&Q Resources

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trade, MDD, Medical Devices, trade deadline, trade-off, nhl, iso 14971, risk management, 14971, FDA, business risk, cmdr

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are..


standards, european commission, IEEE, MDD, Medical Devices, BSI, medical device field, medical device manufacturer, country code, FDA, ASTM, RTCA

Keeping Up With Regulations

In the medical device field the name of the game is Compliance. The reason for..

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..

standards, MDD, iso 14971, medical device, Medical Device Directive, ISO, iso 13485

Making Sense of Standards

You may have heard that last year there were two new releases of EN standards:..

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..