Updates

We have assisted a large company in setting up a patient support program.

We have advised a healthcare provider on compliance with the Dutch Healthcare Quality, Complaints and Disputes Act (Wkkgz), including the implementation of an internal complaints procedure and the appointment of a complaints officer.

We have advised a healthcare institution on the conditions under which medical professional secrecy may be breached.

We have advised a large MedTech company on the structuring of its collaboration with Dutch healthcare providers and healthcare professionals for clinical research and product development purposes.

Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.

Our team negotiated a cooperation agreement between a cosmetics brand owner and a manufacturer on behalf of a mid-sized company.

We advised a mid-sized company on the qualification of a cosmetic product to facilitate its compliant and effective market launch.

We have advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

We have guided several clients through notified body interactions and discussions with competent authorities on product classification.

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.