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Introduction to Regulatory Affairs for Medical Devices

Includes the NEW Medical Devices Regulation

15 - 16 May 2017

Crown Plaza Hamburg

After years of discussion the European Commission recently finalised the new Medical Devices Regulation. This 2-day introductory-level training course will examine the requirements outlined in the new Regulation as well as the existing Directive.

Major topics you will examine include classification, conformity assessment routes, post marketing adverse event reporting and labelling. 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.

  • Learn about the NEW Medical Devices Regulation and how it will impact you
  • Gain a thorough understanding of how the new regulation will change future EU applications
  • Learn how to classify medical devices
  • Determine the correct information required for medical device labelling
  • Understand the role of the Notified 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

Anne has her own consulting company, advising on regulatory affairs and quality assurance to medical technology industries. Anne previously worked for TUV, 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 Certification 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

Course reviews - February 2017

The course was very interactive with lots of opportunity to ask questions. It provided an excellent overview.

Clinical Trial Manager, Europe

, Moximed International GmbH

I was looking for a course which would inform and prepare me for the new MDR. The fact that we could ask questions that arose at any time was great; I enjoyed this course immensely.

Scientific Affairs European Manager, 

Moximed International GmbH

The fact that it was a small group gave us the opportunity to discuss everything with good informal contact with the trainer.

Regulatory Affairs Officer

, Barco N.V

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