Feasibility assessment

 

Risk assessment, regulatory advices, pipeline optimization, global regulatory pathway mapping

 

   

Reimbursement process

 

Cost effectiveness issues, writing and submission of documents in Belgium and in France.

 

Regulatory support

 

Medical and in vitro diagnostic devices, positioning, classification, gap analysis, regulatory compliance, clinical plan development, identification of notified bodies, preparation and submission of technical files, CE marking

 

   

Postmarketing surveillance

 

Clinical evaluation, reporting of incidents and corrective actions, regulatory monitoring

 

Quality system design

 

Gap analysis, settingup ISO9001 and ISO13485, processes mapping, audit of subcontractors according to the ISO13485, writing SOP's, training of the staff, risk analysis

 

   

Financial support

 

For the quality system design, SME can obtain financial support from the Walloon region (accredited consultant)

 


Chemin du Cyclotron, 6 - 1348