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Fundamentals of EU Regulations for Medical Devices

5-week online course | 2 hours per week

7 May - 9 June 2019

Online Academy

Are you ready for the new Medical Device Regulation (MDR)?

In May 2017, the EU issued the new MDR to address weaknesses in the current law relating to medical device safety. As we are quickly approaching 2020, time is running out for the industry to begin facilitating the necessary changes relating to device classification, clinical evidence and safety reporting to remain compliant. This 9-module course will bring you up-to-speed with the fundamentals of the new MDR and the changes you need to understand to avoid costly delays and ensure quick market access for your medical device. Whether you are new to the medical device industry, or simply need an overview of the changes, then this course will provide you with all you need to know regarding the EU regulatory landscape.

  • Grasp the changes that the medical device industry needs to implement to remain compliant with the new regulations
  • Understand how to submit your documentation to ensure your device is in line with the updated general safety and performance requirements
  • Familiarise yourself with the stringent clinical evidence requirements and vigilance reporting
  • Learn to classify your device under the new guidelines
  • Understand the post-market and surveillance requirements
  • Discover best practice for clinical investigations and evaluations reporting detailed in ISO 14155

This course is suitable for professionals who work in the medical device regulatory industry who need to understand the changes in the EU law. Particular areas may include:

  • Regulatory Affairs
  • Medical Device Development
  • Clinical Investigations
  • Chief Operating Officer – Doctors & Nurses etc.
  • Adverse Events Reporting
  • Research & Development 

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 

 

Students will learn through:

  • 9 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months after the end of the course
  • Access the discussion forum to interact with other students
  • Direct contact with the trainers through the forum during the time the course is running
  • Additional content such as course materials available to download
anne jury circle

Anne Jury

Anne has her own consulting company, advising on regulatory affairs and quality assurance to medical technology industries. Anne previously 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. In addition, Anne worked worked for TUV, where she was responsible for the development of the Medical-Health-Sports (MHS) Business Uni

1-2 modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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