Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Regulatory Affairs Professionals Society

San Francisco Bay Area Chapter In Person Event: 2026 Risks with Pharmaceutical & Medical Devices in the Supply Chain

This intensive symposium covers the 2026 pharmaceutical and medical device landscape, focusing on global supply chain ...
News Medical

The effect of the EU GMP Annex 1 on air monitoring programs for medical device manufacturers

Following the most recent revision to the EU GMP Annex1 in 2020, Eric Clement Arakel (Global Product Manager) and Myriam Gueye (Segment Marketing Manager, Applied Industries) at Sartorius will explain ...
Business Wire

Medical Devices Post Market Surveillance and Complaint Handling Systems Course: U.S. FDA CGMP Expectations/Requirements (ONLINE EVENT/ON-DEMAND) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...
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South Korea shifts device change approvals to negative list, speeds GMP checks

The Ministery of Food and Drug Safety on the 3rd gave advance notice of legislation for a revision to the Enforcement Rule of the Medical Devices Act that includes introducing a "negative list" system ...