This 2-day advanced-level course will critically analyse the regulations covered in our 2-day introductory course Understanding the Medical Device Regulation by answering the following questions; what is the process, and what do I need to include to meet regulatory expectations?
These questions will be answered in the context of technical documentation, the vigilance system, the regulatory hierarchy in the EU, labelling, clinical evaluations and investigations, post-market surveillance and post-market clinical follow-up studies.
In addition, this course will critically examine the Medical Device Regulation (MDR) by outlining the reasons for its development, the key regulatory updates to be aware of and what changes the industry must facilitate to ensure continuing compliance for their products.
Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. He has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited
This course is aimed at individuals with a minimum of 3 – 5 years’ experience or those who are a senior level within regulatory affairs for medical devices as the course focuses on managerial and leadership development.