Elevate your medical device testing to global standards
There are multiple regulatory, ethical and business reasons to ensure that all digital healthcare and medical devices are thoroughly tested and secure, including:
Failing to ensure medical device cybersecurity could lead to significant reputational damage for device manufacturers and healthcare organisations that use insecure technology
The FDA, EU and Health Canada are working on standards and guidance documents that will indicate the need to consider vulnerability scans and penetration tests during the development of medical devices. To prevent the need for rework; some of the requirements should be tested early in the process. We address some frequently asked questions here to keep you informed on the latest developments.
TÜV SÜD’s test labs offer you a comprehensive set of assessment and testing activities related to the cybersecurity of your medical device. These include:
TÜV SÜD is a world leader in cybersecurity testing and has worked with medical device manufacturers around the world to assess the quality and safety of their devices. We have extensive experience of conducting testing on a wide range of networked medical devices. Our assessments are based on IEC 62443-4-2, UL-2900-2-1 (based on UL-2900-1), a TÜV SÜD internal checklist and the FDA guidance; thus aiding your compliance to regulations and access to global markets.
The digitization of the medical sector brings with it countless opportunities.
Fulfill requirements of Annex I to the MDR
Fulfill general safety and performance requirements
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