All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...
Once the risk team has been assembled, the crucial process of identifying risks must commence. The output of the risk ...
Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...
MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...
In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...
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