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Medical Devices, medical device industry, FDA, K97-1, Guidance Document, regulatory, 510(k)

FDA 510(k) Memorandum #K97-1 “Deciding When to ...

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum..

best practices, Quality System, autonomy, Guidance Document, Innovation, regulatory, improvements, quality

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our..

medical device review, FDA, Guidance Document, PMA

Acceptance and Filing Reviews for Premarket ...

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I..

RTA, submission, FDA, medical device, 510(k) submission, 510(k) review, Guidance Document, Refuse to Accept, 510(k)

New "Refuse to Accept" Guidance Document for ...

There has been much controversy about the new RTA FDA Guidance document titled..

Clinical Studies, Stents, Guidance Document, Women in Bio, Breast Cancer

October brings awareness to women’s health issues

October is a very important month for women: It’s National Breast Cancer..