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 ...
Indiatimes

Wellthy Therapeutics Announces Expansion into the United States - Completes FDA CFR Part 11, FDA CFR Part 820, and HIPAA Certification for Its Platform

MUMBAI, India and LOS ANGELES, May 11, 2023 /PRNewswire/ -- Wellthy Therapeutics, a global leader in digital health and digital therapeutics, announces the successful completion of its FDA 21 CFR Part ...
Royal Society of Chemistry

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

Unfortunately, that is the case in the overwhelming majority of medical device companies. The benefits of automation and information retrieval systems are not fully realized due to the legacy policy ...
PharmTech

The Impact of 21 CFR Part 11 on Equipment Design for R&D Applications

This article examines the application of 21 CFR Part 11 to those areas of research and development (R&D) where compliance is not strictly required and the response of R&D equipment vendors to the rule ...