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Introduction to Regulatory Affairs for Medical Devices

Practical solutions for compliant medical device submissions

19 - 20 September 2016

Radisson Blu Edwardian Grafton, London

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.

  •  Gain a thorough understanding of how the regulation of medical devices may change in the future for EU applications
  • Learn how to classify medical devices
  • Determine the correct information required for medical device labelling
  • Understand the role of the Notifi ed Body and Competent Authority
  • Examine the risk management process for medical devices
  • Discuss the regulatory challenges of software and methods to tackle these problems

 

Anne Jury

With years of experience within the industry, Anne has set up her own consulting company as an advisor on regulatory affairs and quality assurance to medical technology industries. Before setting up her own company, Anne worked for TUV Product Service Ltd, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Unit through quality assured operational processes, auditing and product testing of MHS products/systems. She also worked for BSI Product Certifi cation as a Medical Devices “notified body” Certification Manager, managing BSI’s regulatory compliance for CE marking to the Active Implantable Medical Devices Directive 90/385/EEC and Medical Device Directive 93/42/ECC.

  • 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

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