TGHOSH & ASSOCIATES

MEDDEV development, compliance & regulatory services

Medical device Pre-development to regulatory filing, documentation and implementation services for Canada, USA, EU markets fully compliant with ISO-13485. MDSAP, 21CFR820 and EUMDD/MDR including hardware/software design & development, risk management, Beta prototype manufacturing and pFMEAs, verification & validation testing, cybersecurity plans, safety/ performance testing, DfX processes, clinical evaluations, summative/formative usability testing and post market surveillance reporting. End-to-end support for technical writing (plans, protocols and reports), auditing, regulatory submissions, amendments and licenses to accelerate transition from prototypes to approved, commercialized medical devices.