Updates

For a client conducting a multinational clinical investigation, we have drafted informed consent notices that allow for long term use of clinical research data beyond the confines of the study.

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.

We have created the data protection strategy for a long-term registry study.

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.

We have assisted a medical device manufacturer in ensuring that their SAAS-application complies with the Data Act and the GDPR.

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.

We negotiate numerous commercial contracts for our clients, including sale, distribution and agency agreements, or support them in doing so with in-depth feedback and negotiation strategy.

We have represented clients in complex commercial litigation proceedings, including claims relating to earn-out disputes in the context of corporate transactions in the life sciences sector.

Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.

We have advised a client on an inspection by the Dutch Healthcare Inspectorate (IGJ).