Seminar - MDR Implementation and Compliance Active and Non Active Medical Devices, Software and IEC 62304 Implementation
This seminar covers critical MDR aspects, including clinical evaluation and Quality Management System (QMS). Our guest speaker from DNV Korea will also discuss on the software lifecycle and IEC 62304 implementation for MDR.
By the end of the seminar, participants will gain insights into several critical aspects related to the Medical Device Regulation (MDR) and its implementation. These include understanding the purpose and principles of MDR, its timeline for adoption, and the interplay between MDR, ISO 13485 Harmonized/Technical standards, and the MDR environment. Additionally, we will delve into the topic of economic operators’ obligations, statutory and regulatory requirements, as well as effective management of product risk following ISO 14971 standards and General Safety and Performance Requirements (GSPR).
The seminar will also cover the alignment of EN ISO 13485:2016 with ISO 14971:2019 and TR 24971, exploring their impact on MDR GSPR. Interpretation of MDR requirements and guidance documents issued by the Medical Device Coordination Group (MDCG) will be addressed. Lastly, participants will gain insights into the specific requirements for economic operators, including Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-up (PMCF), as well as the crucial roles played by economic operators and notified bodies within the EU MDR framework. A session on software and IEC 62304 implementation will also be covered by our invited guest speaker from DNV Korea.
Who shall attend?
This seminar is tailored for personnel across the medical device industry, including CEOs, CTOs, senior executives, engineers, regulatory staff, and quality managers. It aims to equip participants with the knowledge and practical skills necessary to understand and implement Medical Device Reporting (MDR) within their organizations.
This is a paid seminar with limited seats. Upon completion of the seminar, a certificate of attendance will be issued to participants.
Visits our registration for detailed agendas and payment information!
Presenter:
Kim Jin Ho
Auditor, Supply Chain & Product Assurance, DNV Korea
Before joining DNV in 2021, he served as the Medical Device Technical Documentation Assessor at Korea’s Ministry of Food and Drug Safety (MFDS). With over 10 years industry experience, he specializes in regulatory affairs, having also worked as a CRO regulatory specialist and a Quality Manager in medical device manufacturing. He holds a master’s degree in biomedical engineering and specialized in HIFU (High-Intensity Focused Ultrasound) therapeutic ultrasound and HIFU driving system.
Thillainathan Ramaya
Lead Auditor, Supply Chain & Product Assurance, DNV Singapore
With 19 years of industrial experience, he specializes in Quality Management Systems (QMS), validation, and risk management related to medical device design, development, manufacturing, sales, and distribution within the medical devices industry. Thillainathan is a trained Medical Device Lead Auditor and holds a portfolio for auditing various schemes, including ISO13485, MDR, IVDR, and MDSAP, covering a wide range of medical devices—from passive and active to IVD medical devices.
Dr. Namrata Hange
Integrated Clinician, Supply Chain & Product Assurance, DNV Singapore
Dr. Namrata is a clinician specializing in Public Health, with 17 years of experience in Public Health-RWE research and healthcare consultation. As a clinical researcher, she holds double master in public health and possesses abundant experience in research methodologies, analytical skills, and problem-solving capabilities. Her tenure with WHO India has further honed her analytical acumen and innovative problem-solving abilities.
Visits our registration for detailed agendas and payment information!