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Regulatory updates for the medical device industry

Numerous standards covering cybersecurity - which guidance should you use? Along with other partners TÜV SÜD have done extensive research work and complied an open guidance document.

Open guidance document on cybersecurity

Over the years, digitalisation has help increase the connectivity of medical devices. However, the convergence of technologies poses challenges and risk relating to cybersecurity. These potential impact on clinical care and patient safety is a raising concern for healthcare organisations, regulators and medical device manufacturers. As such, the need to protect data and devices from cyber-attacks is well understood.

Cybersecurity for medical device is not a new topic. While you will find numerous standards and guidance documents covering the topic, there is currently no international standard for cybersecurity of medical devices. Furthermore, there are many varying local (e.g. United States and Germany) guidance documents and standards for cybersecurity in other industries. So, which guidance should you use to help guide you in your planning and decision processes?

The Johner Institute, along with TÜV SÜD and other partners have done extensive research work and complied an open guidance document on cybersecurity. This open guidance presents key information on the most relevant conformity requirement on cybersecurity. It establishes the importance of protection based on the CIA triad; Confidentiality, Integrity and Availability and demonstrates compliance with state-of-the-art cybersecurity requirements.

You can download the open guidance document for free here:

Guidance on cybersecurity

Furthermore we offer a free webinar “Cybersecurity of medical devices – requirements of the Notified Body” on 13 December, Thursday at 10am CET or 5pm CET.

This webinar will explore and explain how notified bodies can assist with tackling this issue, including:

• The role of a notified body regarding cybersecurity during audits and technical documentation assessments.
• An evaluation of currently available standards.
• How a technical services provider can help with cybersecurity testing

Register here:

Register here for our free webinar at 10am CET
Register here for our free webinar at 5pm CET

internal coding: 23NOV2018_TÜV SÜD Product Service GmbH_PS_MKG_MHS_blog_2.0_de_DE


E-ssentials MedDev Team

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