Serving both the In Vitro Diagnostic and Medical Device industries worldwide since 1995, MDSS specializes in the “Authorized Representative” service according to European CE marking regulations (MDD 93/42/EEC, AIMDD 90/385/EEC; IVDD 98/79/EC).  The Authorized Representative is the main contact for the European Commission and the National Competent Authorities. 

The MDSS team includes physicians, Engineers and IVD experts dedicated to providing the best customer service.

Certified to EN ISO 13485 – MDSS consults on quality- / risk management systems and all related CE – approval services. Our portfolio covers: support and services in product registration, classification, incident reporting, recall management, labeling, advice of technical files and consulting on European regulatory affairs, quality system regulations, clinical evaluation, conformity assessment, technical file review and set-up, risk management, usability assessment, software validation, sterilization validation, vendor assessment, etc.