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.
Diagnostics
Food and Feed
Commercial Contracts
Intellectual Property and Licensing
Spin-out and Starter Advisory
Testimonial
Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.
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.
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
On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.
