An introduction to the European Medical Device Regulations
Sponsored by: AMPLEXOR Life Sciences
- M D R
- European Medical Device Regulations
- Medical Device Manufacturers
Date: 25 April
Time: 3PM London/10AM New York
The impact on industry and your business
Over the next few years the Medical Device industry will need to adapt to the Medical Device Regulations (MDR), which come in force by May 2020. The new Regulations promote a full life-cycle approach impacting Regulators, Notified Bodies as well as Medical Device Manufacturers. The new Regulations include new features, new requirements and far more detail than the old device directives. As this imposes risks your business continuation, Medical Device companies are advised to know the implications and start preparations on time.
During our webinar, we will explain on a high-level what the new regulations mean, provide you with insights on the business impact and allow you to ask questions to one of industry foremost MDR expert. The provided insights will allow you to understand the most important changes and when they will become effective. Causes and benefits that allow you to understand how and when to prepare.
Within the webinar, we will answer practical questions you might have concerning your day to day business, including:
- Should we re-certify under MDD or under MDR?
- Will we be able to stay with our current Notified Body?
- How do we know if we are ready for certification under MDR?
Professor Herman Pieterse,
Professor in Clinical Pharmacology at the University of Ghent
Technical Qualifications and Accreditations
Professor Pieterse studied Pharmacology at the Free University in Amsterdam. In 1977, he joined Boehringer Ingelheim and held functions in Research and Development, including, Clinical Research Manager for clinical pharmacology and International Medical Project leader for a cardiovascular research compound and Associate head of the Medical department.
In 1984, he started working for Rhone-Poulenc as Medical Director. In 1988 he changed to Ovabloc Europe and took responsibility for international registration and research as Director of Regulatory Affairs and Technical/ Clinical Research. Since 1991, he founded the Consultancy and Interim Management Agency PROFESS Medical Consultancy B.V. and assists now several major companies in the healthcare industry with both regulatory and quality assurance issues, GCP clinical development and training.
In November 1996 Herman became a certified ISO 9000 Lead Auditor IRCA no. AO11064.
Managing Director - Iperion
With more than 18 years of experience within the life sciences industry, as a project manager, Stulp is specialized in management of IT projects for Regulatory Compliance, and has been the Program Manager of the first completed IDMP implementation program. Stulp supports several clients as IDMP program advisor. He has been a member of the EMA ISO IDMP Task Force and is an active speaker on IDMP on conferences and webinars.
Key Learning Objectives
- What is MDR?
- What does it mean to me?
- What should I be doing about it?
- When should I begin preparing for it?
- Product Life Cycle Planning
- Notified Body Selection
- Regulatory Document Writing
- Device Registration
- Clinical Evaluation
- Post Market Surveillance
- Research & Development
- Regulatory Affairs
- Product Development