M2 - Design, Risk and Safety Standards - Planning for Content Deviations in ISO 14971:2012 (QP)

About this course

A one day course specifically dedicated towards managing the additional focus from notified bodies and EU regulatory agencies associated to the content deviations within ISO 14971. We discuss the background to the deviation and identify the specific elements in your risk management documentation that need to be reviewed and addressed in order not to fall foul of the content deviations. A practical and informative course that will enable you to review your current approach to risk management and compare it with the expectations of your notified body.

Who Should Attend

Development, regulatory, quality and product safety professionals responsible for the coordination of risk management activities.

Course outline

This is a new course offering for Medical Devices and part of our Qualified Person programme for Medical Devices.

For more information please call our team on +441142 541270

E-mail our training and education team at: [email protected]

Venue

Manchester - Venue to be confirmed

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Tutors

The tutors for this course are as follows:

• Duncan Keeble
• Marcus Orton

• 

  James Pink
  Medical Devices, Vice President
  

  • [email protected]
  • +44 (0) 1143 600868

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