About

Raksha Raghavan is a biomedical engineer with over five years of experience in the field of medical device development. She has a deep understanding of product quality in accordance with Quality management system (ISO 13485) & Risk Management (EN ISO 14971:2012) standards, along with medical device testing, working as a Systems Engineer in a Startup environment. Raksha's areas of experience in the field of Medical Device Development include Product Verification, ISO 13485, 14971, 100793 & IEC Standards, Class 2 Medical Device Development, Technical File compilation for EU CE Marking, Literature research, Risk assessment and Formulating verification protocols, and Documentation for Quality Systems. Raksha is currently working as a Quality Assurance Specialist in Quality & Regulatory Affairs at Leica Microsystems. She is responsible for ensuring that the company's products meet regulatory requirements and quality standards. Raksha has worked in the past as a Member Of Technical Staff| Regulatory Affairs - Medical Devices at HCL, where she performed Gap Assessment for medical devices to comply with New Medical Device Regulation (2017/745), mapped out Applicable Standards for Class I Hoist lift system, performed Standard Assessment for products, and remediated the risk management files, design requirements specification, instructions for Use, Labelling as per the new requirements based on MDR. Raksha was awarded the LIVE WIRE award for best performance, first time right and On time deliverable in MDR project for the 4th Quarter 2018, HCL Technologies. Raksha also worked as a System Engineer at ezemrx, where she was responsible for setting up Medical Product Development Division for the company with a mission to innovate affordable and quality medical devices to improve patients “Quality of Life”. She worked as a Systems Engineer performing the roles of a Quality representative, Verification Engineer, and on the clinical front, acted as a bridge between Engineering and Medical Practitioners, documented clinical workflow, and provided clinical inputs to product requirements. Raksha holds a Bachelor of Engineering in Biomedical/Medical Engineering from B.M.S. College of Engineering. She also completed Pre-University education in Science and Mathematics from Sri Bhagawan Mahaveer Jain College and High School education in Science from Carmel Convent School. Raksha's tech stack includes QA, test, Research Scientist, and Software Engineer. With 6.11 years of relevant experience, Raksha is noted for delegating tasks effectively, providing constructive