Medilink Midlands will cover an update on the current changes to Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and the role of the person responsible.
The next MedTech Regulatory Special Interest Group (SIG), hosted by regulatory affairs expert Richard Young, from AcclaimBiomedical Consulting, will provide a comprehensive update on the current MDR and IVDR landscape, plus an overview of the requirements and practical considerations needed within a company to meet regulatory compliance.
Young will be joined by Anne Jury, a regulatory affairs consultant with over 18 years of experience in the medical and diagnostic healthcare products industries, and Alexander Pearce, Educo Life Sciences, well experienced in helping medical device professionals develop their skills and knowledge through learning and development.
During the presentations, they will cover:
- Introduction to current changes to requirements MDR & IVDR
- ISO13485 minimum Quality Management Systems (QMS) requirements
- Clinical Evidence
- General Safety and Performance Requirements (GSPR)
- Lay Users (individuals who do not have formal education in a relevant field of healthcare or medicine display)
- Roles of the Person Responsible for Regulatory Compliance (PRRC)
There will be time at the end of the presentations for a Q&A session. For more information, you can click here.
