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Home > Medical Device made Easy Podcast > Cybersecurity in Medical Devices – What QA/RA Must Do Today
Podcast: Medical Device made Easy Podcast
Episode:

Cybersecurity in Medical Devices – What QA/RA Must Do Today
Category: Business
Duration: 00:00:00
Publish Date: 2025-09-10 23:51:31
Description:
miniature Episode 353 Cybersecurity in Medical Devices – What QA/RA Must Do Today monir el azzouzi easy medical device

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 like the NIS2 Directive and the EU AI Act

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