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EU MDR/IVDR Guidance List Provides Insight on 2019 Expectations

Get ready for an active fourth quarter in the European Medical Device..


Q&A: FDA Updates for Medical Device Manufacturers

From new software and cybersecurity guidance to updates to existing medical..


"Hope isn't a strategy." Takeaways from RAPS and ...

September was an incredible month for us at R&Q. Our thought leaders were out..


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..


Two sides of the regulatory coin

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


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..


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

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


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,..