help another medical device manufacturer introduce their new branded products to the global market by managing their product market authorizations for remediated products of a medical device company in 50 non-US countries, thus systems in the domestic market under a FDA consent decree.With our commitment to service

registration and device listing, medical device reporting (MDR) and complaint handling, CE marking, vigilance reporting, standards and guidelines, FDA regulatory Medical Device Reporting (MDR) and European vigilance reporting systems, performing regulatory audits, preparing Technical Files and Design Dossiers, managing