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Advanced Regulatory Affairs for Medical Devices

Includes the NEW Medical Devices Regulation

7 - 8 February 2018

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

 

Kath Clarke

Kath Clarke is a Regulatory Affairs professional with 30 years’ experience in the Medical Device Industry. She started her career in the Medical Device Industry working for Smith & Nephew, during which time she held a variety of Quality Assurance and Regulatory Affairs roles. After 20 years Kath moved to Tissue Science Laboratories, where she held the position of Regulatory Affairs Manager; her responsibilities included CE marking, vigilance reporting, liaison with the Notified Body and product registration in global markets.

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, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:

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

Medical devices software development and applications

Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 

 

 

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