Updates

Our sustainability team has assisted a client in drafting a sustainability code of conduct.

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

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

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

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 assisted a client in setting up a multinational data strategy, including advice on anonymisation of personal data and interaction product regulations and the upcoming high-risk regime under the European Health Data Space Act (EHDS Act) to help them continue innovating without endangering company confidential developments.

We set up procedures for multiple clients continues transfers of personal data beyond the EU, including to countries without an adequate data protection regime, for various purposes.

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.