Our technical team including medical device experts and experienced assessors support you to provide the technical documentation according to the MDR Requirements. We will support you from star of the project until obtain CE Certificate in all stage of certification process including communication with your Notified Body.

We will review your current situation based on requirements relevant to the classification of medical device (Class I (Sterile)/ I (measuring)/ I (surgical re-usable), Class IIa, Class IIb and Class III) and perform a comprehensive GAP ANALYSIS. Output of Gap Analysis will be used as pathway to compliance with the MDR.

Our clinicians, who are experienced evaluators, will help you to provide the Clinical Evaluation according to the MDR and relevant MDCG documents. We will identify the best pathway for clinical Evaluation to speat up the process. This includes Clinical Evaluation, Clinical Investigation or Trial (if required), Literature, etc.