R&Q Resources

Upcoming and on-demand education, commentary from thought leaders, Q&A features, and more.


Not signed up for updates? 

regulatory, EU MDR, CERs

🔑 Unlock the Secrets to CERs in our May Webinar

Unlock the secrets to complying with the increased requirements for CERs in..

FDA, regulatory, regulatory strategy, draft guidance

Review Controls Applied to Outgoing Data Streams ...

Medical device manufacturers need to carefully manage several important outward..

Quality System, regulatory, massmedic

Free Webinar: CAPA on CAPA, Presented by ...

CAPA is often overlooked as an integral component of a quality system. More..

RAPS, industry guidance, regulatory news, regulatory, Industry Advice

Industry Advice: Earn RAC Points and Enhance Your ...

You've already read a few benefits in the title but let's reiterate: Earn RAC..

india, labeling, medical device industry, medical device, compliance, regulatory, registration

India Medical Device Labeling

This week I will provide some information about labeling in India. CDSCO..

Regulatory and Quality Solutions, RQS, regulatory, Regulatory Pathways

Same Road (Regulatory Pathway), Different Car ...

As you might expect, here at RQS the responsibilities and duties of providing..

software system, regulatory focus, www.fda.gov, FDA, FDA website, maude database, software, regulatory, Graematter, Regulatory Intelligence

Regulatory Intelligence

How much time to you spend searching FDA’s website? Looking for predicates,..

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


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