Raina M.

Background

About Raina M.

Working as Regulatory Affairs Executive in Translumina Therapeutics Private Limited "Lead successfully the Medical Device Regulation’s Technical File Documentation remediation for a German Class Permanent Implantable Medical Device Organization (Translumina GmbH), achieving Conformity with EU MDR 2017/745 & supporting timely Submission on 05th December, 2024 for Yukon Chrome PC (Sirolimus Eluting Coronary Stent System – Cobalt Chromium) to PCBC Poland, Notified Body (1434), Sirolimus Eluting Coronary Stent System - Cobalt Chromium, Polymer Free Sirolimus Eluting Coronary Stent System - Cobalt Chromium & Polymer Free Everolimus Eluting Coronary Stent System - Cobalt Chromium for Translumina Therapeutics India Translumina is the Manufacturer of Drug Eluting Stents, Vascular Accessories, Drug Coated Balloons, PTCA Balloon Catheters, PTCA Guidewires, Guiding Catheters & High Pressure Balloons KRA's- Preparation of Summary of Technical Documentation (STED)(As Per EU MDR 2017/745), Compilation of Technical File (As Per EU MDR 2017/745), Design Dossier Preparation (As Per EU MDR 2017/745), Design & Development (D&D) Summary (As Per EU MDR 2017/745), Declaration of Conformity (DoC)(As Per EU MDR 2017/745), Preparation of Device Master File (As Per IMDR 2017 & ISO 13485:2016), Performing Gap Analysis, Maintaining Quality Management Systems (QMS), Preparation of General Safety Performance Requirements (GSPR), Preparation of Details of Device, GS1 Data Kart Entry, Preparation of Product Familia Equivalency, Review of Technical Documents (Biocompatibility (Plans & Reports), Performance Testing (Reports), Instructions for Use (IFU), Labels, Brochures, Patient Leaflet & Implant Card.