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Q&A: Integrating CERs and Post-Market Surveillance

While we're in the midst of taking the summer off from webinars (see you in the..

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Two sides of the regulatory coin

One of the most rewarding aspects of regulatory work is that no two days are..

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That's a wrap! A recap of our Advanced EU MDR and ...

In March R&Q partnered with the Medical Alley Association in Minneapolis and..

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R&Q adds former TÜV Rheinland North America Lead ...

Regulatory & Quality Solutions (R&Q) continues to grow aggressively – all while..

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What does Brexit mean to your medical device ...

Hope for the best, but prepare for the worst.

Medical Devices, News, R&Q, EU MDR, R&Q Hires

Welcome, Jacob Foster: Regulatory and Quality ...

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory,..

QMS, News, iso 13485, AAMI, Resources

ISO 13485:2016 Companion Handbook Now Available

ISO has published a companion handbook to ISO 13485:2016, Medical..

News, medical device news, Jake O'Donnell

NEWS: Bill Introduced to Improve FDA's Medical ...

Senator Johnny Isakson [R-GA] Note: This post is written by Jake O'Donnell,..

Medical Devices, quality systems, News, iso 13485, R&Q, Minnesota

Minnesota Momentum: R&Q Hires Member of ISO ...

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory...

News, FDA, 510(k) submission, regulatory news, compliance, 510(k)

What You Should Do About the Two New FDA Draft ...

It has been a long journey for the FDA to get the new draft guidances published..

biosense, News, wearable tech, sensors, innovations, wearables

Wearables are Exploding (Not Literally!) and ...

Image via Verily Smart wearables are turning into a largely profitable..