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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..


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

Clarifying the Clinical Evaluation Requirements: A Case Study

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


cybersecurity, FDA

The Lowdown on Cybersecurity for Medical Devices

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


MDSAP, FDA

MDSAP: A Better Inspection Option for Device Manufacturers?

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


webinar, audits, MDSAP, FDA

MDSAP: What is it? Is it for me? How will I get it done? [Webinar]

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


FDA, regulatory, regulatory strategy, draft guidance

Review Controls Applied to Outgoing Data Streams (Because the FDA Might Be)

Medical device manufacturers need to carefully manage several important..


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

Acquisition Regulatory Assessments: A Case Study

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


FDA, Conferences, CDER, CDRH

The REdI Fall 2016 Conference: Slides and Recordings

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


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

Revamping Supplier Quality: A Case Study

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


Case Studies, FDA, CAPA, remediation, CAPA remediation

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

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