CE Marking and FDA Marketing Process◗ Classification of medical devices, in vitro diagnostics and borderline products◗ Regulatory & strategic consulting◗ Gap analysis of existing documentation◗ Preparation of standard technical documentation / design dossier / 510(k) / PMA◗ Management of pre-clinical trials for e.g. biocompatibility, clinical trials, clinical evaluation report◗ Toxicological expert statements, material characterization, biological evaluation◗ Management of clinical trials, clinical evaluation report◗ LabellingInteraction with Notified Bodies & Regulatory Authorities◗ European Authorized Representative (EAR) services◗ US Agent services◗ Product registration◗ Assistance with response to inspectional findingsOther Services◗ Implementation or review of QMS/QRS and risk management plans◗ On-site regulatory and strategic support◗ Training on European, Canadian and FDA medical device regulations, ISO 13485 & ISO 9001 requirements◗ Internal audits, supplier audits & pre-regulatory inspection audits

Sales and Marketing Executive

Marktleitung/ Store Manager