How to effectively protect your systems with cybersecurity

With the continuous development of digital health applications (DiGA) and the increasing networking of medical devices, the demand for data security is growing: cybersecurity is dedicated to the protection of information and communication technology.

What manufacturers of medical devices should look out for

Patient protection is the top priority. It is essential to protect their health and data from damage caused by cyber attacks. This is already of great significance for reasons of medical confidentiality.

The EU Medical Device Regulation (MDR) and technical guidelines issued by the German Federal Office for Information Security (BSI) also regulate the implementation of cybersecurity in medical devices. International regulations that you should also keep an eye on are the MDCG 2019-16 and the FDA guidance on cybersecurity for medical devices.

Step by step towards cybersecurity for medical devices

Based on national and international standards, you should ensure the cybersecurity of your medical devices with a well thought-out concept. Here is how you can proceed with this:

  • Consider the quality system and the content of applications – before placing on the market. Document everything.

  • Implement cybersecurity in the quality management system (QMS) and in processes.

  • Conduct cyber security risk management.

  • Ensure cybersecurity within the software and system architecture.

  • Create your own cyber security concept (if you wish).

  • Implement the concept incl. E2EE, etc.

  • Test your implementation with penetration tests.

  • After market launch: Continue to search for weaknesses and breaches in the monitoring and control measures.

  • Repeat the points above if necessary

Take your medical device to a new level – with cybersecurity

Wir helfen Dir gerne dabei, die Cybersicherheit zu gewährleisten und prüfen Deine Produkte und Unterlagen vor der Einreichung oder Markteinführung. Nur so kannst Du sicher sein, dass Deine Medizinprodukte sicher sind.

So kannst Du auf globale und rasante Bedrohungen schnell reagieren. Mit der Konzeptionierung und Integration von Schutzsystemen unterstützen wir Dich in allen Fragen der Cybersecurity für Deine vernetzten Medizinprodukte, Mobile Medical Apps und DiGA. Dabei helfen wir Dir, die europäischen und internationalen Regulatorien zum Schutz der Patient:innen zu beachten.