Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...
CHICAGO--(BUSINESS WIRE)--Cypris Medical, Inc., a company committed to improving outcomes by making plastic surgery less invasive, announced today that an extensive independent audit of its quality ...
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 ...
THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with ...
ZAVENTEM, Belgium, May 20, 2025 (GLOBE NEWSWIRE) -- SYNDEO Medical, a Belgian-based developer of interventional procedure solutions, is pleased to announce that it has received ISO 13485 certification ...
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 ...
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 ...
Rellingen, September 18, 2025 – Viromed Medical AG ("Viromed"; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, has received the ISO 13485 certification. This ...
With the publication of the 2000 revision of the general ISO quality systems standard, the medical device industry has concluded that it must follow a separate course. A pending update to the industry ...
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