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 medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was time that ISO 13485 reflected that evolution. The global standard for ...
The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which ...
Our recent interview with Garth Conrad, Vice President, Quality, at C.R. Bard, now part of BD, discussing the revision of ISO 13485, the international standard for medical device quality management ...
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 ...
Dublin, Jan. 27, 2026 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (May 21, 2026)" training has been added to ...
The problem with solving trade within the public health protection sphere is the sincere obligations that regulators have to protect their own people. As a result, what happened at the GHTF can be ...
This is the On-demand recording of The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices. All medical device manufacturers supplying ...
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 ...
GREEN BAY, Wis.--(BUSINESS WIRE)--Pioneer Metal Finishing, LLC ("Pioneer"), is pleased to announce the ISO 13485 certification of its Medical Center of Excellence facility in South Bend, IN. “This ...
Hoggan Scientific, LLC, a globally recognized leader in the design and manufacture of medical devices, is proud to announce that it has successfully received recertification for ISO 13485:2016, the ...
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
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