Title : Guidance to Medical Device Startups on QMS ISO 13485:2016
Date : 17th March 2021 16:00 17:30
Abstract : Many view Quality Management System (QMS) as a necessary evil for a medical device company— something you must have in order to be compliant. A QMS is often times seen as the set of procedures that define the rules and restrictions that must be followed in the quest for designing, developing, and manufacturing medical devices. Few understand the importance of QMS being beneficial. And most companies implement QMS that is largely rule-based, restrictive, cumbersome, and largely ineffective. The conventional approach for establishing a quality management system is that of addressing compliance to regulations—sometimes resulting in direct regurgitation of requirements defined in ISO 13485:2016 and other quality system requirements and regulations An introduction for anyone involved in the development, implementation and management of a QMS based on ISO 13485
Speaker : Ms Divya Ganapathy
Ms. Divya Ganapathy is a Founder of Regulatory1, a consulting company specialized primarily in the area of Medical Device, IVD and Pharma. She is a Regulatory Expert and Certified Lead Auditor for ISO 13485. She has been an Advisor and Trainer for many startups in India and EU, BETIC -Mumbai, SriChitra- Kerala, Vilgro, SINE and Swissnex India. • She has more than15 years of experience in manufacturing, consulting, certification, preclinical, non-electrical, clinical trial and training in various organizations. • Her manufacturing experience relates to IVD and Medical Device product development, engineering support, regulatory strategy, import export, clinical coordinator, ISO auditor and quality assurance. • She is trained in UL -Ochenhausen, Germany for Medical Device Testing which includes Electrical, Biocompatibility, preclinical and clinical studies • Being a Certified Lead Auditor for QMS standards, she has completed more than 75 Internal audits and certification audit at National and International market. • She has also jointly audited for USFDA audit and GMP facility at International level. • Currently supporting manufacturers for testing, documentation, implementation for QMS and regulatory requirements.