The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...

Shenzhen Sungrow LED Technology Co., Ltd., the parent company of Wakelife Beauty, has recently secured the prestigious ISO 13485:2016 certification for its medical device quality management system.

This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated ...

RUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and ...

Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets ...

This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for ...

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...

Dublin, Aug. 06, 2024 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets ...

The new ISO 9001:2015 standard and the anticipated reboot of ISO 13485 could create hurdles for medical device manufacturers. Thomas C. Bowles Recent months have seen extraordinary changes in the ...

The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard. In February 2026, the FDA will move away from ...