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 like the NIS2 Directive and the EU AI Act

We finish with a practical checklist for QA/RA teams to assess their readiness today.

Cybersecurity isn’t about perfection—it’s about showing regulators you are in control.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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