Learn how incorporating human factors principles in developing the PCCP approach can improve the chances of successfully implementing a PCCP.
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Archive: FDA
Integrating FDA’s new cybersecurity guidance into medical device human factors engineering processes
Connected medical devices offer benefits but also pose cybersecurity risks that can disrupt patient care. The FDA’s new guidance highlights the need for strong cybersecurity measures and provides recommendations for integrating these measures into human factors engineering to ensure device safety.
FDA’s digital health precertification program emphasizes importance of post-market surveillance
Finding efficient ways to leverage post-market surveillance data to inform product development at an institutional level will be key for SaMD manufacturers seeking FDA precertification.