The FDA has identified numerous medical device recalls in 2023 and 2024, many of them due to software issues. Smiths Medical, a major player in the industry, faced recalls of syringe pumps due to software problems and a lack of evidence of compliance with FDA regulations. The complexity of modern software, including AI and machine learning, presents challenges for the industry in meeting regulatory standards. Outdated methods of documentation and traceability using tools like Excel further complicate the process. Utilizing technology and modern tools, along with a focus on risk management, can improve patient safety and innovation in the field of medical devices.
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From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
