Advanced Regulatory Affairs for Medical Devices

The regulatory environment for medical devices is in a transitional period. With the increased focus on patient safety, the MDR has introduced many changes to the requirements and processes involved.

Designed for professionals with a working knowledge of medical device regulatory affairs, this course will provide essential guidance on how to successfully transfer products from the current regulatory system under the Medical Device Directive (MDD) to the new MDR. Regulatory strategy and life cycle management will be a key focus of the programme with comprehensive sessions on regulatory pathways, technical documentation, clinical evaluations and investigations. There will also be a review of the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies.

Delegates will cement the knowledge gained through case studies and practical workshops and there will be ample opportunity to discuss the complexities involved with two medical device experts, both of whom have huge knowledge and experience in this field.

This event would be an excellent follow-on course from our three-day programme An Introduction to the Medical Device Regulation.