The auditor, an IRCA Approved Lead Auditor for EN ISO 13485:2016 & ISO 9001:2015, boasts over 21 years of experience in India's medical devices manufacturing sector. With roles like Asstt. General Manager at companies such as Medorah Meditek Pvt. Ltd. and Iscon Surgicals Limited, they've overseen quality assurance, regulatory affairs, and process improvement. Their achievements include setting up new manufacturing units and ensuring compliance with ISO standards and regulatory requirements like MDD 93/42/EEC & EU MDR 2017/745. Holding an MBA in TQM, the auditor has undergone extensive training in quality management systems auditing and regulatory compliance, embodying reliability and a passion for excellence in the industry.