The "An introduction to Risk Management ISO 14971:2019 Training Course (Apr 27, 2026)" has been added to ResearchAndMarkets.com's offering. Understand the use of risk management in the medical device ...

If you’re involved in medical device packaging, you’ve got a lot of support these days, with even more on the way. The latest revision of ISO 11607-1/2: 2019, “Packaging for terminally sterilized ...

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

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

CE Certification Allows Shipment of DOBI Medical's ComfortScan(TM) System to European Union Countries Planned for Q4, 2004 DOBI Medical International, Inc. (OTCBB:DBMI.OB) announced today that the ...