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 ...
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 ...
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.
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 ...
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 ...
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 ...
Dublin, April 12, 2023 (GLOBE NEWSWIRE) -- The "Risk Management in the Medical Device Industry - Understand Iso 14971" training has been added to ResearchAndMarkets.com's offering. Medical Devices by ...
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 ...