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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.

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 Regulatory Compliance and Enforcement Testimonial

We have advised a medical device manufacturer on the qualification and classification of a borderline product, including the determination of the correct regulatory pathway under the MDR and the mitigation of associated compliance risks.

Medical Devices Litigation Testimonial

One of our lawyers has acted as arbiter in international proceedings on MDR compliance.

Medical Devices Litigation Testimonial

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

Medical Devices Data Protection, (Cyber)security and AI Due Diligence Regulatory Compliance and Enforcement Testimonial

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

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

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

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.