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Advanced Regulatory Affairs for Medical Devices

Gain advanced tools necessary to implement regulatory requirements

5 - 6 February 2020

Radisson Blu Edwardian Grafton, London

Aimed at professional with a working knowledge of regulatory affairs, this advanced course will provide a road map on how to transition from the current regulatory system based on directives to the new one established by the regulation. The course will include comprehensive sessions on; technical documentation, the vigilance system, the regulatory hierarchy in the EU, labelling, clinical evaluations and investigations, EUDAMED, post-market surveillance and post-market clinical follow-up studies.

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 and future challenges for industry.

This course provides a great follow-on from our 2-day programme Understanding the Medical Device Regulation.

  • Understand the reason behind the new Medical Device Regulation
  • Explore the changes to roles and responsibilities of key stakeholders including competent authorities, notified bodies and economic operators
  • Investigate classification rules and processes, including software products
  • Analyse the General Safety and Performance Requirements and technical documentation requirements
  • Examine the guidance and requirements for clinical evaluations and investigations
  • Understand the different conformity assessment routes
  • Comprehend market surveillance tools such as EUDAMED and UDI
  • Implement effective post-market surveillance and vigilance strategies
  • Understand the different requirements and types of post-market clinical follow-up
  • Critically analyse the impact of Brexit and future trends/challenges in the industry

Mika Reinikainen

Mika has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.

He has more than 30 years of experience managing European medical regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.

He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide.  

He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).

This course will provide experienced professionals with the regulatory knowledge to practically apply life-cycle management in an MDR environment, particularly to those who play a key role in transitioning their products to the MDR.

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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