About Us
We are a team of experts with backgrounds in Engineering & Regulatory Affairs which over decade of experience with some of widely known medical device manufacturers. The idea of establishing this consulting was conceived while working on large scale transfers of R&D centers. We are currently assisting a list of diverse small & marge medical device companies in this space, in their journey. Our goal is to take away your MDR worries, so that you can focus on just the Product.
Services
General Requirements
EU Declaration
Quality Management System
List of all UDI-DI (GTIN)
Summary of safety and clinical performance
Risk Management
Risk Management Plan
Risk Management File
Risk Management Report
Technical File Documentation
Device description and specification
Manufacturing process and process validations
Labelling and IFUs
Clinical
Clinical Evaluation Plan
Clinical Investigation Plan
Clinical Evaluation Report
Clinical Investigation Report
Post-Market Surveillance
Post-Market Surveillance Plan
Post-Market Surveillance Report
Periodic Safety Update Report
Post-Market Clinical Follow-up Plan