MedilinkWM and Acclaim Biomedical Consulting bring to you practical training sessions designed around the delegate. These intimate sessions are designed to maximise learning outcomes and they are created to promote interaction and discussion.
The aim of the course is to help attendees to develop a greater understanding of the expectations of clinical evidence and PMS when considering both Medical Devices and In Vitro Diagnostic. The course will involve a combination of theory and practical sessions. The course will also provide tools and references to help plan how to ensure clinical data is continually gathered, analysed and reported to comply with these new regulations.
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 course will include the following topics:
-Updates on the Regulations and their impact on clinical evaluations.
-How to design Clinical Trials, including how the MDR will affect post market clinical studies for existing products.
-How to perform a Clinical Literature Review.
-Managing CERs (Clinical Evaluation Reports) throughout the life cycle of a medical device, including practical guidance on how to prepare a clinical evaluation report. This will include reference to the MED DEV 2.7.1 Rev 4
The course is designed to review critical elements of the new regulations and will be run as an interactive 1-day course designed for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices and In Vitro Diagnostics, in addition to those who would like to further their working knowledge of current requirements.
£150 Medilink Members
£190 Non Members
For any further information, please contact:
Vanessa Bailey, Events Coordinator, Medilink West Midlands at – email@example.com