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By Mark F. Witcher, Ph.D., biopharma operations subject matter expert | This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks. |
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By Allan Marinelli and Abhijit Menon | In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies. |
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By Brett Mason, Troutman Pepper | As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare to navigate new legal challenges. |
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| Reduce Human Error In Healthcare Operations | White Paper | HID | Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care. |
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