The course is designed to review critical elements of the new regulations and is suitable for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices, in addition to those who would like to further their working knowledge of current requirements.
The aim of the course is to help you develop a greater understanding of the medical device regulations for the manufacturers of Medical Devices. The course will also provide tools and references to ensure that companies are able to comply with the new MDR.
Why Should You Attend:
The Medical Device Regulation (MDR), which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) will come into effect in May 2020. The new MDR requires significant changes to the clinical evidence that Manufacturers must document, with more clinical data being required for higher class devices. This course will discuss the requirements that manufacturers of medical devices must follow in order to comply with the Regulation.The aim of the course is to help you develop a greater understanding of the medical device regulations for the manufacturers of Medical Devices. The course will also provide tools and references to ensure that companies are able to comply with the new MDR.
Areas Covered in the Webinar:
- Introduction to Medical Device Regulation in Europe - background
- Updates on the Regulations and their impact on CERs (Clinical Evaluation Reports)
- How to design Clinical Trials, including how the MDR will affect post market clinical studies for existing products
Who Will Benefit:
- Quality managers
- Regulatory affairs
- Manufacturers
- Clinical managers
- Product development managers
- Project managers
Speaker
Rebecca KembleCourse Provider
Rebecca Kemble,
