Cybersecurity for your Medical Devices with Erik Vollebregt
Let’s see if what is shown in movies is correct. Can some hackers take control of a Hospital or kill you by hacking an insulin pump. Is this science fiction or reality. In this episode of the Medical Device made Easy Podcast, we will focus on cybersecurity for Medical Devices.
The new Medical Device Regulation is providing more information on Softwares and this is due to the progress done which can then lead to some issues. Erik Vollebregt will be my guest on the podcast to explain to us:
- What manufacturers should do to comply with the regulations?
- Which guidance they should follow?
- Is it the same in all the countries?
Don’t forget to look at the links with all the guidance that we discussed today.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.
Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.
He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission.
Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.
Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyers: https://www.axonlawyers.com/
- Erik’s blog post on Cybersecurity: https://medicaldeviceslegal.com/2020/03/16/the-mdcg-cybersecurity-guidance-a-helpful-rush-job
- MDCG 2019-16: https://ec.europa.eu/docsroom/documents/38924
- ENISA handbook: https://www.enisa.europa.eu/publications/handbook-on-security-of-personal-data-processing
- IMDRF Principles and Practices for Medical Device Cybersecurity: http://www.imdrf.org/consultations/cons-ppmdc.asp
- BSI cybersecurity for devices white paper: https://www.bsigroup.com/en-US/medical-devices/Resources/Whitepapers-and-articles/