Latest / The Med Device Cyber Podcast
Cybersecurity Qs MedTech Innovators Ask: Christian’s Hot Seat
MedTech manufacturers, how can you avoid the cybersecurity pitfalls that most often lead to FDA rejection?
In this episode, Trevor puts Christian “in the hot seat” to tackle the most common—and sometimes misunderstood—cybersecurity questions MedTech innovators ask. Christian breaks down key concepts such as ISO 13485, HIPAA vs. FDA expectations, SAMD vs. SIMD, global regulatory demands, and more.
Key points:
(00:30) The purpose of ISO 13485 and why traceability, quality, and documentation are foundational to medical device safety.
(02:34) How cybersecurity is now the most common reason FDA…
The skinny
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