1. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau ToHealth e-learning course on medical devices Julia Henschel

2. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau What is ToHealth? The ToHealth project represents an online e-learning course on medical devices focusing on regulatory affairs and requirements for placing medical devices on the market within the European Union. 4 September 2014 ToHealth, Julia Henschel, European Workshop 2

3. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau What is ToHealth? Leonardo Da Vinci for Livelong Learning Programme (LLP ) Innovationtransfer Duration Time: 10/2013-10/2015 www.tohealth.eu 16 October 2015 ToHealth, Julia Henschel, European Workshop 3

4. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau What is ToHealth about? The ToHealth online course will include contents on the following: EU Medical Device Regulatory Overview Medical Device Quality System and Process Requirements Medical Device Technical Specifics 16 October 2015 ToHealth, Julia Henschel, European Workshop 4

5. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau Who is ToHealth? ToHealth consists of several European institutions from Poland, Spain, Italy and Germany. Each of these institutions has a long experience in their working field (research, development regulatory affairs, IT, e-learning services). 16 October 2015 ToHealth, Julia Henschel, European Workshop 5

6. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau For whom is ToHealth? ToHealth is being developed for companies or organizations which are involved: in the design development manufacture or distribution of medical technologies and medical devices As well as companies or organizations seeking to expand their business into the medical device sector. 16 October 2015 ToHealth, Julia Henschel, European Workshop 6

7. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau How is the knowledge depth of ToHealth? The online course is intended to provide : A basic body of knowledge for training purposes for employees in-depth information for employees with a medical device background 16 October 2015 ToHealth, Julia Henschel, European Workshop 7

8. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau What are the learning objectives? Overview of the European regulatory framework for medical devices. Requirements applicable before devices may be placed on the market. Pan-European registration requirements. Requirements applicable in the medical device design, development process and requirements applicable throughout the device lifecycle. 16 October 2015 ToHealth, Julia Henschel, European Workshop 8

9. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau In-depth knowledge of key points for medical device design including risk management, usability engineering and clinical evaluation. Medical device quality requirements. Medical device vigilance system and post-market requirements. Know and identify the different groups of biomaterials and learn about their applications. 16 October 2015 ToHealth, Julia Henschel, European Workshop 9

10. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau How is the method? This course is in an online environment Intuitive and highly interactive Communication and learning tools This tools include: Dynamic teaching units Activities Forums Internal messages and email 16 October 2015 ToHealth, Julia Henschel, European Workshop 10

11. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau How is the method? 16 October 2015 ToHealth, Julia Henschel, European Workshop 11 Six different modules Final exam Duration : 38-40 hours

12. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau How is the method? 16 October 2015 ToHealth, Julia Henschel, European Workshop 12 Multiple sessions Standard sessions include a set of resources Last session Last session: Review, further information, self-evaluation Session A.1 Session A.2 Session A.3

13. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau How is the method? 16 October 2015 ToHealth, Julia Henschel, European Workshop 13 Previous ideas Objectives Lessons Teaching Unit Activities Last session: Review, further information, self-evaluation Session A.1 Session A.2 Session A.3

14. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau What are the course modules A.Introduction to European Medical Device Regulatory Requirements B.Medical Device and Development Lifecycle C.Medical Device Risk Management, Usability Engineering and Clinical Evaluation D.Medical Device Quality System Requirements E.Medical Device Vigilance System and Post-market requirements F.Biomaterials 16 October 2015 ToHealth, Julia Henschel, European Workshop 14

15. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau Example Module A - Introduction to European Medical Device Regulatory Requirements Upon completion of this module, learners shall be able to: Identify current EU applicable legislation, standards and guidance. Explain the main steps to enable access to the medical device market. Identify critical processes and procedures applicable in the post- market phase. 16 October 2015 ToHealth, Julia Henschel, European Workshop 15

16. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau Timeline 16 October 2015 ToHealth, Julia Henschel, European Workshop 16 1th October 2013 31th October 2015 now Analysis and definition of the training course contents Creation and updating website Pilot course Course objectives Course guide Dissemination activities Validated courseTranslation of the course Content of modules and sessions Configuration of the multi-language e-learning platform Questionnaire

17. Institute of Biomechanics Paracelsus Medical University Salzburg Trauma Center Murnau 16 October 2015 ToHealth, Julia Henschel, European Workshop 17