R&Q Resources

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


 In the midst of the coronavirus pandemic and reduced travel/networking, please remember our Resources page offers the latest education, training, and industry information from R&Q. 


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News, FDA, EU MDR

Emergency Use Authorization Stories, Part I: The Humn Project

As we collectively watch the world struggle to cope with the devastating..


FDA

MDUFA IV: More Than Just User Fees - FDA ...

Pending the expected signature of President Trump, MDUFA IV will be implemented..

remediation, FDA, Case Studies, Clinical Evaluation Report, MEDEV 2.7/1

Clarifying the Clinical Evaluation Requirements: ...

About R&Q's Case Studies: We hope this Clinical Evaluation Report case study is..

cybersecurity, FDA

The Lowdown on Cybersecurity for Medical Devices

Every one of us has probably either been affected by or knows someone who has..

FDA, MDSAP

MDSAP: A Better Inspection Option for Device ...

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal..

webinar, audits, FDA, MDSAP

MDSAP: What is it? Is it for me? How will I get ...

Part of your month, every month: R&Q Intelligence Series webinars are held on..

FDA, regulatory, regulatory strategy, draft guidance

Review Controls Applied to Outgoing Data Streams ...

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

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 case..

FDA, CDER, CDRH, Conferences

The REdI Fall 2016 Conference: Slides and ...

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum..

warning letter, remediation, FDA, supplier quality, Case Studies

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation case study..

remediation, FDA, Case Studies, CAPA, CAPA remediation

When CAPA Needs a Corrective Action: A CAPA ...

About R&Q's Case Studies: We hope this case study is valuable to you. Here are..

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..