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MDD, News, EU MDR

BREAKING NEWS: European Parliament Approves One Year EU MDR Delay

This post is an update to our recent blog post where Nancy Morrison, R&Q's..


MDD, News, EU MDR

COVID-19 Continues to Impact Medical Device ...

Medical device companies often have a globally distributed workforce which can..

MDD, News, EU MDR

How Will COVID-19 Impact the EU MDR Timeline?

Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting..

MDD, News, EU MDR

New EU MDR Guidance on Significant Changes

As most of the world seems to be at a standstill this week, the European..

MDD, News, EU MDR

EU MDR 2017/745 Health Check List

Check out R&Q experts' European Union Medical Device Regulation (MDR) 2017/745..

MDD, News, EU MDR, Brexit

Brexit: Top Five Do's and Don'ts for Medical ...

After four years, many heated debates, several delays, and a few Prime..

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: