R&Q Resources

FDA | This is where you'll find our webinars, events, and more.


Are you signed up for updates? Subscribe here.

FDA

MDUFA IV: More Than Just User Fees - FDA Reauthorization Act (FDARA) Passes Senate

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


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FDA, regulatory, regulatory strategy, draft guidance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..

FDA, Ohio, BioOhio, Regulatory 101, Regulatory 201

July is a BIG month for R&Q in Columbus, OH

■ ■ ■ Are you an Ohio Bioscience Expo & Showcase attendee here to register for..