DONGGUAN, GUANGDONG, CHINA, January 13, 2026 /EINPresswire.com/ -- As healthcare moves toward proactive and at-home ...

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

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 ...

The International Organization for Standardization (ISO) 10993 series provides guidelines for the biological evaluation of medical devices, ensuring the safety from their intended use. This series ...

ISO 14971 provides a framework for medical device manufacturers to identify and minimize risks through the design and manufacturing processes. Adhering to the standard helps ensure overall safety and ...

DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

The contract research organization will launch an expanded ISO 18562 gas pathway testing program and ISO 10993-18 particulate ...

E-BEAM Services, Inc. validates its Quality Management System for Medical Devices by attaining ISO 13485 certification and renewing ISO 9001 accreditation at three of its ebeam processing facilities, ...

Fake ISO certificates claiming safety and quality of medical devices need to be verified: Experts: Shardul Nautiyal, Mumbai Thursday, January 15, 2026, 08:00 Hrs [IST] Experts hav ...

BORDEAUX, France--(BUSINESS WIRE)--FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully Implantable Cardiac Output Management System designed to address ...