In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment,...
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In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment,...
In this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF for your Medical Device products. Jessica has over 20 years of experience in medical product development. She started her career in a medical device startup, working directly with physicians and end user...
RCA Radio
In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment,...
