Tacit Medtek

TACIT MedTek is support /service company. We facilitate companies in the field of medical devices and In-Vitro Diagnostics. Quality and consistency in the regulatory dossier compilation and support services are our prime focus. CE Technical File Preparation (as per EU MDR 2017 / 745) US FDA 510K filing ISO 13485 Implementation and gap analysis in the existing QMS. Various application for India Approvals for medical devices / IVDs. Regulatory filings in US/EU/GCC/India/Latin markets. Transition of existing technical file from MDD to MDR. CE Marking as per MDR 2017/745: Complete Notified Body Coordination till Technical File Approval. Gap analysis in the existing documentation and remedial action plan to fill the gap. Help to identify correct equivalent / predicate device for comparison. Update documents like GSPR, Risk, Clinical, usability etc as per latest standards Help to generate the clinical data and prepare the Clinical Evaluation Report. Identification of EU Rep. EU complaint labelling and UDI set up. Report Preparations: Risk management plan and Report as per ISO 14971 Clinical Evaluation Report Design Verification and Validation Report Usability Report Design History File Biocompatibility Evaluation Matric and Report India – Medical Device and IVDs Registrations: Manufacturing License and Loan License Permission Import Registration Device Master File (DMR) & Plant Master File (PMF) preparation as per India MDR Clinical Investigation Permission Voluntary Registration and Test License Labeling & promotional material compliance review for with Indian regulations Others: Support for various testing requirements and applicable standards for global filings Help companies to set up and streamline Regulatory Affairs process Handling the queries and Post-Approval Amendments Market intelligence and Techno-Commercial filing strategies. Medical Devices ISO 13485 site audit and compliance support Facility Design and Validation Documentation