Our team advised a client on the registration process under REACH.
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We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.
We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.
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.
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.
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.
We have assisted a medical device manufacturer in assessing whether its product is eligible for reimbursement under Dutch healthcare insurance law.
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 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.