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