Medilink WM 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 you develop a greater understanding of the expectations regarding clinical evidence and PMS for the manufacturers of both Medical Devices and In Vitro Diagnostic. The course will involve a combination of theory, practical sessions and case studies. The course will also provide tools and references to support organisations to plan how to ensure clinical data is continually gathered, analysed and reported to comply with the new MDR.
This course will discuss how clinical data should be collated, with emphasis on the requirements of the new Medical Device Regulation (MDR).
The following topics will be discussed:
• Overview of medical device regulation in Europe
• Introduction to clinical evaluations
• Designing and managing a clinical evaluation
• Post-market clinical follow-up (PMCF) studies for existing products
• Overview of ISO 14155 and GCP
• Clinical evaluation throughout the product lifecycle
• Updates on the regulations and their impact on clinical evaluations
• How to perform a clinical literature review, including practical guidance on how to prepare a Clinical Evaluation Report (CER)
The course is designed to provide an introduction to Clinical Research and ISO14155. The course is aimed at anyone who is new to Medical Devices, In Vitro Diagnostics or clinical research. The course is also applicable to those who would like to further their working knowledge of current requirements.
Medilink member cost: £150
Non-member cost: £190
To register to attend this event, please click here. If you have any queries or require further information, please contact Vanessa Bailey.