Advanced Regulatory Affairs for Medical Devices
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).
Emphasizing regulatory strategy and lifecycle management, the program 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.
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Reviews by course attendees
Average rating 4.2
I had fun in the classification part, and I was interested in classifying medical devices in a different way than in Korea.
I had fun in the classification part, and I was interested in classifying medical devices in a different way than in Korea.
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
I thought it covered a vast area in great detail and was evenly paced. Both speakers were excellent and extremely helpful during question time