Reinforcing Quality Management Systems through Greater Alignment of ISO 13485:2016 & the EU MDR
Medical device companies are undergoing one of the most significant regulatory evolutions to date, as new ISO standards and the EU Medical Device Regulation (MDR) come into effect with increased stringency and liability for manufacturers. The final MDR contains explicit requirements for manufacturers to establish, implement and oversee a quality management system (QMS), and while ISO 13485 is not specifically required under the MDR, it is the recognized industry standard for comprehensive product design and manufacturing. A thorough understanding of ISO 13485:2016 and its relation to the MDR will allow for concurrent implementation and greater overall QMS administration.
- Practical insight for implementing ISO 13485:2016
- Existing and future relationships with ISO 9001
- Transitional arrangements and related timescales
- Impact upon global regulatory requirements
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Quality Assurance
- Quality Systems Management
- Regulatory Affairs
Technical Manager – Medical Devices
John has worked for LRQA for the last 2 years having joined form another established Notified Body, where he worked for more than 30 years, the most recent 12 years in the role of Head of Notified Body. Widely recognised for his expertise within the medical device industry, John has represented the Notified Body on a wide range of European and UK medical device committees, where he was actively involved in the review and implementation of the medical device directives and associated guidance documents before being selected as an expert witness in the House of Commons Select Committee inquiry into the regulation of medical implants.
John is qualified in Mechanical & Production Engineering and has extensive experience in Quality Assurance in general and has been actively involved as Lead Auditor against the requirements of ISO 13485 since its inception. Over this time his experience has extended from auditing the largest of corporations through to the smallest of organisations and start-ups. John is well respected for his thorough and proactive approach that he has gained within the medical sector and which he applies to his current work within the ISO 13485 accreditation, certification and training activities within LRQA.
Technical Specialist – Medical Devices
Flemming Nielsen has worked at LRQA for 10 years. As a Technical Specialist for Medical Devices, he is responsible for unannounced audits under the MDD and QMS activities “MDD linked to ISO 13485”. Flemming is currently involved in the assessor training for ISO 13485, whilst prior to his current position, he has worked as an LRQA Lead Auditor within the MDD, IVDD, CMDCAS, ISO 13485 and ISO 9001 schemes. Flemming has more than 14 years’ experience in the Medical Devices industry, and prior to joining LRQA has worked in Quality departments of several Medical device manufactures.
1 Hour Video | Anindita Saha and Martin Ho, Center for Devices and Radiological Health