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 ...

Dublin, Sept. 29, 2025 (GLOBE NEWSWIRE) -- The "An introduction to Risk Management ISO 14971:2019 Training Course (Nov 11, 2025)" training has been added to ResearchAndMarkets.com's offering.

The EU Commission caused quite a stir in August 2012, when it announced the harmonization of the EN ISO 14971:2012 risk-management standard for the medical device industry with absolutely no ...

Medical device quality management system aligns with latest version of globally recognized risk management standard. Greenlight Guru, the only medical device quality management system (MDQMS), today ...

In the wake of rising cases of medical device software defects and malfunctions, software quality assurance and compliance with regulation has come to the forefront of discussion among industry ...

The U.S. FDA has endorsed ISO 14971 for risk management for medical device manufacturers, but there’s nothing compulsory about industry’s use of this standard. Nonetheless, Sarah Moore, principal ...

(MENAFN- GlobeNewsWire - Nasdaq) The medical device industry's shift towards risk-based regulatory compliance presents key opportunities. Mastery of ISO 14971:2019 enables enhanced risk management ...

Medical device quality management system (MDQMS) aligns with latest version of globally recognized risk management standard "This iteration of the ISO 14971 standard is the first update in nearly 13 ...