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Advanced Regulatory Affairs for Medical Devices

Gain advanced tools necessary to implement regulatory requirements

18 - 19 September 2019

Hotel Berlin, Berlin

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.

Delegates will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit.

  • Critically analyse the full impact of the Medical Device Regulation (MDR)
  • Explore the changes to roles and responsibilities of key stakeholders
  • Identify common problems and solutions through open discussions with your course leader and peers
  • Gain advanced tools necessary to optimise and maintain your regulatory procedures
  • Understand the correct procedure for the processes at each stage of the product life-cycle

Richard Young

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.

ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, this 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session

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