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,...
503 Compounding: Challenges, Compliance & the Road Ahead
RCA Radio
16 minutes
6 months ago
503 Compounding: Challenges, Compliance & the Road Ahead
In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies. Together, they explore the critical role compounders play in personalized medicine, their differences from traditional pharmaceutical manufacturers, and the increasing regulatory scrutiny they face—especially 503B outsourcing facilities. The discussion covers: The origins and types of compounding pharmacies (503A vs. 503B)...
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,...
