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

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Food and Feed Medical Devices Pharmaceuticals Due Diligence Testimonial

Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.

Medical Devices Regulatory Compliance and Enforcement Spin-out and Starter Advisory Testimonial

We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.

Cosmetics Regulatory Compliance and Enforcement Testimonial

Axon assisted a cosmetics company facing enforcement by the Dutch Food and Consumer Product Authority NVWA re. the sample service it operated. Axon advised the company on the applicable CPNP notification and labelling requirements, based on which the company could ensure compliance.

Medical Devices Regulatory Compliance and Enforcement Testimonial

We have assisted a manufacturer of medical devices in obtaining a derogation from conformity assessment procedures under the MDR in the interest of public health.

Medical Devices Regulatory Compliance and Enforcement Testimonial

We have provided in-house training for the authorised representative of a large multinational on its obligations under the MDR.

Medical Devices Litigation Testimonial

Our lawyers have acted as expert in national litigation cases on MDR compliance in other EU Member States.

Healthcare Medical Devices Pharmaceuticals Data Protection, (Cyber)security and AI Testimonial

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.

Digital Health Medical Devices Data Protection, (Cyber)security and AI Testimonial

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

Medical Devices Data Protection, (Cyber)security and AI Testimonial

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.

Medical Devices Data Protection, (Cyber)security and AI Testimonial

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