Yahoo Finance

US FDA QMSR ( Quality Management System Regulation) Transition Course: Harmonization of 21 CFR 820, Device CGMPs (QSR), to the ISO 13485 (ON-DEMAND)

Dublin, June 28, 2024 (GLOBE NEWSWIRE) -- The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of ...
EDN

GPMG Product Helps Medical Device Specification Developers be FDA and ISO 13485 Compliant

GPMG's Vice President and General Manager, Aaron Lyon notes that “This new product will allow medical device developers seeking ISO 13485 certification to meet 85-90 percent of their goal on day one.
Becker's ASC

FDA plans to use ISO 13485 for medical devices regulation

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation ...
SF Station

Corrective Actions – Current expectation of ISO 13485 and FDA auditors

Details:This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review ...
Royal Society of Chemistry

Webinar on FDA and Overview of ISO 13485 by Global Compliance Trainings

FDA has been utilizing information based on inspections conducted by third parties and other regulators in different circumstances pursuant to MDUFMA 2002. This webinar is intended to help you get ...