Episode breakdown:
00:00 – Why Cybersecurity is a New FDA Blocker
02:50 – Meet Blue Goat Cyber: Medtech-Only Cybersecurity
04:18 – FDA’s 2023 Final Guidance on Cybersecurity
07:00 – 68% of Devices Are Network Connected (Here’s the Risk)
09:45 – Why Retrofitting Security Fails
13:30 – FDA Risk Management: ISO 14971 vs TIR5717:10 – Secure Software Dev: IEC 62304 & Who Actually Follows It
20:08 – Is ISO 27001 Enough? What the FDA Actually Wants
25:53 – Most Common Deficiency: Insecure Design
30:30 – Blue Goat’s 5-Phase Submission Strategy
36:30 – Hidden Costs of Submitting Late (Cyber ROI)
40:00 – When to Engage Cyber Experts (and What Happens if You Don’t)
Don’t Let Cybersecurity Risks Delay Your Medical Device Premarket Approval. Check out BlueGoatCyber.com
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