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Cybersecurity in Medical Devices – What QA/RA Must Do Today
Cybersecurity in Medical Devices – A QA/RA Perspective
Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence.
In this article (based on the podcast episode), we explore:
How to prepare cybersecurity documentation for audits and inspections
Building post-market processes for vulnerability handling and reporting
Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…)
Managing supplier and open-source component risks
Implementing and maintaining an SBOM
Key trends…
The skinny
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