Harsh Modi

Background

About Harsh Modi

A dedicated professional in a field of Biomedical Engineering with more than 8 years of Quality Engineering and Regulatory Affairs experience in medical device industry. Thorough knowledge in all aspects of hardware/medical device development phase with extensive knowledge of FDA, China FDA, EU MDR 2017/745 requirements. Technical expertise: • 8 + years of Quality Assurance and Regulatory Affairs experience in medical device industry • Lead Technical File Gap assessment as per EU MDR 2017/745 • Lead CMR 1A/1B and EDC substances evaluation as per GSPR Section 10.4 • Lead 0.1% w/w calculations and justifications as per MedTech Europe Guidance V 2.0 • Hands on experience with Review, update and draft QMS procedures and protocol for regulatory compliance • Update Risk Management plan, report, DFMEA, AFMEA and Hazard Analysis Check as per PSM report • Create /Update Usability Engineering file as per IEC 62366 : 2015 (UOUP) • Update the Manufacturing Process Information as per MDR requirements • Update the IFU and Labels as per MDR requirements • Assist bio compatibility assessment as per 10993-1:2018 • Expertise in design history file, device history file maintenance • Certified Internal Auditor (ISO 13485:2003/ Cor 1:2009 by TSQ) and Experience with supplier audits • Understanding of device verification, validation IDE or bench tests or animal tests, medical device commercialisation pathways. • Strong understanding of good laboratory protocols (GLP), current good manufacturing practice (cGMP) 21 CFR 820. • Hands on experience with UDI compliance and maintenance for class II devices. • Good at medical device classification paths and regulatory pathways • Experience with medical device development phases, medical instrumentation, product reviews for new technology, clinical trials and prototype validation and verification procedures • Successfully led transition projects for complaint handling units within/outside Medtronic. • Comprehensive knowledge of regulatory affairs and medical device development protocols • Hands on experience in customer complaint management, calibration and maintenance of ICU devices • Hands on Experience with 3500A US FDA and European Vigilance. • Extensive knowledge of medical device standards and FDA protocols • Experienced in trend reviews, trend data and CAPA initiation activities. • Experienced in assessing trend charts on Non-conforming reports, complaints and metrics.