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

Design & development

– Regulatory assistance

– Quality management system

– CE-marking guidance

– Audits

– Training

– Consulting

Clinical evaluation

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

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

Surveillance

– Scientific watch / Scientific publications

– Updating of the literature review / Clinical evaluation reports

– Post-market follow-up

– Consumer surveys

– Medico-marketing studies