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Advanced Regulatory Affairs for Medical Devices

Includes the NEW Medical Devices Regulation

6 - 7 February 2019

Radisson Blu Edwardian Grafton, London

The final text of the Medical Devices Regulation (MDR) has now been approved by the European Parliament and with a likely implementation date in 2020, it is time for industry to learn, prepare and implement the new requirements.

The European regulatory landscape will be changing significantly, with the Regulation set to impact areas such as classification, clinical investigations and risk management.
This course will prepare and equip you with the knowledge and confidence to develop optimal regulatory strategies, ensuring compliance during this period of change.

Through a combination of theory and practical discussion, this course will allow participants will build on their existing regulatory knowledge to develop improved tactics, ensuring speedy market access and effective life-cycle management of their products.

We also have an intro level training on this topic, click here to check out the dates>>

  • Examine the NEW Medical Devices Regulation (MDR)
  • Discuss strategies to implement the new MDR with the expert and peers
  • Exploring the changes to roles and responsibilities of key stakeholders
  • Gain advanced tools necessary to optimise and maintain your regulatory procedures
  • Improve your day-to-day management of regulatory affairs
  • Identify common problems and solutions through open discussions

 

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

Professionals working within the field of regulatory affairs at an operational and strategic level:
• Regulatory Affairs Head/Director/Manager
• Quality Assurance Management
• Product and Marketing Managers
• Strategy Management
• Regulatory Affairs Attorney and other legal counsel requiring a substantial regulatory compliance background

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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