Advanced Regulatory Affairs for Medical Devices In-house Training

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Format: Bespoke training
CPD: 12 hours for your records (depending on your requirements)
Certificate of completion

Course overview

Explore the MDR's updates enhancing patient safety and understand its revised requirements and processes to navigate the evolving regulatory environment effectively.

This course is crucial for professionals already versed in medical device regulatory affairs, offering indispensable guidance on transitioning products from the current Medical Device Directive (MDD) framework to the new Medical Device Regulation (MDR).

Emphasising regulatory strategy and lifecycle management, this course includes in-depth sessions on regulatory pathways, technical documentation, clinical evaluations, and investigations. Participants will also delve into requirements for the vigilance system, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) studies.

Through interactive case studies and practical workshops, delegates will solidify their knowledge and engage in discussions with two experienced medical device experts, navigating the complexities of regulatory compliance effectively.

This course serves as an ideal continuation from our comprehensive three-day program, An Introduction to the Medical Device Regulation, offering advanced insights and practical skills essential for regulatory professionals in the evolving medical device landscape.

This course is part of our range of Medical Devices training courses

Who should attend

This course will provide experienced medical device professionals with the practical regulatory knowledge to apply life cycle management in an MDR environment, particularly those who play a key role in transitioning their products to the MDR, including: