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

TACIT MEDTEK

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