CONSTELLATION MED

Medical Device Development with endless potential Our group offers state of the art comprehensive services for your medical device projects: from proof of concept to manufacturing, clinical evaluation and market access WHAT WE DO : We offer a variety of services to our clients including PROOF OF CONCEPT From idea to 1st prototype, state of the art prototype manufacturing and design techniques to develop functional prototypes to evaluate device ideas. REGULATORY PATH Best market strategy including regulatory strategy to keep development time as short as possible. PROJECT MANAGEMENT Complete device project management from scratch to a full CE Mark / FDA submission and even post market evaluation. V&V TESTING Full design verification and validation conducted within our testing facility with the highest testing standards PRECLINICAL TESTING Renowned KOL with access to advanced preclinical testing facility to assess device performance. MANUFACTURING From small production lots to high volume manufacturing, ISO 8 clean room designed for production ramp up. PRODUCT POSITIONING AND MARKET ACCESS Access to KOL training centers for product launch, pre-market evaluation and early post market surveillance.