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Introduction to Regulatory Affairs for Medical Devices

Course Objectives

This practical 2-day introductory-level training course will examine the complex processes involved in meeting the EU regulatory requirements associated with  medical Devices.


The European Commission are currently undertaking a further complete Revision (Recast) of the regulatory requirements. Learn about these proposals and the latest developments and how these will affect you in the future


From early decisions regarding the most appropriate conformance route of a product, through to post marketing adverse event reporting, delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety.

Course Highlights

  • Gain a complete overview of the latest MDD regulations
  • Determine the most appropriate conformance route for your products
  • Meet the requirements for clinical data evaluation
  • Examine the role of risk management throughout the lifecycle of your medical devices
  • Work effectively with EU Regulators to gain clarification

Media Partners

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clinica, advanced regulatory affairs for medical devices, regulatory affairs, medical devices, pti global, pti, pti europe

 

scrip, business intelligence, pti, pti global, pti europe, european regulatory affairs, regulatory affairs

Who Should Attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into Regulatory Affairs from other areas within a medical device company (Clinical Trials, Marketing and others
  • Anyone wishing to update their knowledge on EU regulatory affairs

Download Latest Information Now

(updated 21 April 2014)

Dates and Venues

09 Jun 2014 - 10 Jun 2014

Radisson Blu Edwardian Grafton

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