Prasad Bhatambarekar

About Prasad Bhatambarekar

A seasoned, result oriented & trusted Mechanical Engineer with 8+ years of experience in…

Experience

1. Senior Research and Development Engineer

   BD

   Feb 2020 — Present

   R&D SME supporting the transitioning of the multi-billion-dollar portfolio, meeting the new European CE marking requirements for medical devices (EU-MDR). • Submitted nine (9) Class IIa files to notified body (NSAI) and received certifications for six (6) Class I sterile devices from the total sixteen (16) product families within a span of three (3) years. • R&D SME responsible for developing strategies and interact with notified body to address queries received, which resulted in obtaining the MDR certificate with minimal query rounds. • Reviewed and provided inputs to Summary Technical Documentation (STED), General Safety and Performance Requirements (GSPR), Risk Management, Material compliance & Labelling documents to comply with EU MDR requirements and/or regulation. • Performed Design History Files (DHF) gap assessment for Class I and II acquisition products (Blood Collection needles/Wingsets/Lancets/Accessories) for material change, design modification and remediation in accordance with EU-MDR. • Led R&D team and liaise with cross functional teams – Quality Assurance and Regulatory Affairs to develop ISO 23908, ISO 11607 & ISO 9626 compliance memo for acquisition products in accordance with EU MDR. • Designed and conducted simulated studies (CAD) in lieu of actual testing to validate claims and remediate gaps in support of MDR for Blood Collection Needle, Wingsets, Lancets & Accessories device designs through design review, product validation, and generated engineering rationale, resulted in significant cost savings. • Assisted in generating Design Traceability Matrix (DTM) with design inputs and engineering requirements for specific product, packaging, and process specifications. • Developed protocols and reports for Design Verification testing for the parameters identified as gaps during MDR remediation. • Validated testing to ensure Class I & Class II medical device design meets the regulatory guidelines as specified under EU MDR.