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 ...

FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by ...

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to ...

FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards The US Food and Drug Administration (FDA) in late December recognized the newly revised International Organization for ...

Dublin, Jan. 15, 2026 (GLOBE NEWSWIRE) -- 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 ...

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 ...

Medical devices, like physicians, should do no harm. That’s a given in the healthcare space, and ISO 14971 is an international standard that provides medical device manufacturers with a risk ...

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 U.S. FDA’s emphasis on internationalized regulations continues with the agency’s adoption of ISO 14971, the risk management framework published by the International Organization for ...