July 14, 2022
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...
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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:...
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Latest News!

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.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact

Corporate Office

15148 Springview St.
Tampa, FL 33624
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