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Updates

Explore our latest insights, regulatory updates, and strategic reports for the life sciences sector.

Chemicals Regulatory Compliance and Enforcement Testimonial

Our team advised a client on the registration process under REACH.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

Medical Devices Regulatory Compliance and Enforcement Testimonial

We have advised numerous manufacturers on MDR and IVDR compliance, including guiding a small medical device company through the conformity assessment procedure with its notified body.

Healthcare Data Protection, (Cyber)security and AI Testimonial

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

Healthcare Commercial Contracts Regulatory Compliance and Enforcement Testimonial

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.

Healthcare Regulatory Compliance and Enforcement Testimonial

We have assisted a healthcare start-up with the regulatory requirements for establishing a healthcare institution in the Netherlands, including the required permits and governance structure.

Healthcare Medical Devices Regulatory Compliance and Enforcement Testimonial

We have assisted a medical device manufacturer in assessing whether its product is eligible for reimbursement under Dutch healthcare insurance law.

Healthcare Regulatory Compliance and Enforcement Testimonial

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.

Digital Health Healthcare Regulatory Compliance and Enforcement Testimonial

We have advised a digital health start-up on the qualification of its services under Dutch healthcare law, including the determination of whether the company qualifies as a healthcare provider and the resulting regulatory obligations.