R&Q Resources

510(k) | This is where you'll find our webinars, events, and more.

remediation, FDA, 510(k) review, 510(k), Case Studies, Acquisitions

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments..


submissions, PMA, 510(k), advamed

Master 510(k), IDE, and PMA Submissions at ...

Within driving distance to D.C.? There's still time to enjoy a few days there..

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..

510(k) submission, 510(k) review, 510(k), advamed, Workshops, Education

Hear R&Q and Other Industry Experts Discuss ...

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other..

Q-Sub, FDA, Guidance Document, Pre-Sub, PMA, 510(k), Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the..

FDA, 510(k) review, 510(k), CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is..

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..

3d printing, FDA, medical device, 510(k), additive manufacturing, oxford performance materials

Medical “Wow”: 3D Printed Skull

Last week I saw several articles published about a new device that is going to..

medical device industry, taxes, FDA, medical device, public health, govenment, regulatory, 510(k), CDRH

Headaches

The FDA received funding to increase its workforce at the CDRH for 2012 and..

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..