Healthcare
Medical Devices
Pharmaceuticals
Data Protection, (Cyber)security and AI
Testimonial
What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.
Digital Health
Medical Devices
Data Protection, (Cyber)security and AI
Testimonial
We have assisted a medical device manufacturer in ensuring that their SAAS-application complies with the Data Act and the GDPR.
Medical Devices
Data Protection, (Cyber)security and AI
Testimonial
We have advised a medical device manufacturer on collaborations with academic institutions on data collection for training of AI systems, including the necessary data protection contracts.
Medical Devices
Data Protection, (Cyber)security and AI
Testimonial
We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.
Medical Devices
Data Protection, (Cyber)security and AI
Testimonial
On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.
Medical Devices
Data Protection, (Cyber)security and AI
Due Diligence
Regulatory Compliance and Enforcement
Testimonial
We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.
