FDA is requesting input on patient safety, including best practices to promote patient safety, education, and competency, associated with Non-Medical Device Software – software excluded from the medical device definition by the 21st Century Cures Act. Software professionals should take this opportunity to explain the risks associated with non-medical device software interacting with medical device...Read More
Company: Becton, Dickinson and Company Date of Enforcement Report: 6/22/2022 Product: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers Reason: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Recalling Firm/Manufactuer: BD (Becton, Dickinson and Company) on 6/22/2022. Voluntary:...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.