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 ...
Yahoo Finance

US FDA Medical Device Quality System (QSR) Compliance Course: Design Controls, Verification & Validation (Online Event: Oct 27th - Oct 28th, 2025)

Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...

DEK Strengthens Medical CNC Machining With ISO 13485 Quality Systems

The company advances precision CNC machining for medical device components with ISO 13485–aligned quality control and ...
JD Supra

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical ...
Design-Reuse

Global Unichip Achieves Critical ISO 13485:2016 Certification for Medical Device Components

Hsinchu, Taiwan, Oct. 25, 2017 – The leading custom ASIC company, Global Unichip Corp. (GUC), today announced the achievement of highly coveted ISO 13485:2016 certification, which make GUC the first ...
MD&M East

Benefits of ISO 13485 Certification for Medical Device Manufacturing

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...