The world of medical devices is changing fast. As a result, technical and clinical requirements are getting stricter at every stage of a device’s life-cycle in response to the demand from authorities to make healthcare products safer.

In view of these developments, manufacturers are increasingly calling on external expertise to guide them through the CE-marking and post-market follow-up processes.

In this context, we offer a service based on identifying and analysing your needs and providing bespoke advice.
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Euraxi is a member of the DM EXPERTS network

Design & development

Regulatory assistance

Quality management system

CE-marking guidance

Audits

Training

Consulting

Clinical evaluation

– Identification of your clinical strategy and analysis of existing data

Literature review / Writing and updating of clinical evaluation reports

– Clinical investigation project design

Implementation, follow-up, analysis and exploitation of clinical investigation results

Patient support programme / Home trial support

Placement on the market

– Study design proposal / Advice on methodology / Sample calculation / Finding scientific experts

– Studies concerning reimbursement requests and requests from authorities

– Design and analysis of post-market clinical follow-up plans (PMCF)

– Establishing registries and medico-economic studies

Surveillance

– Scientific watch / Scientific publications

– Updating of the literature review / Clinical evaluation reports

Post-market follow-up

– Consumer surveys

Medico-marketing studies