institute of biomechanics paracelsus medical university salzburg trauma center murnau tohealth...

Institute of BiomechanicsParacelsus Medical University SalzburgTrauma Center Murnau

ToHealth e-learning course on medical devicesJulia Henschel


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 2014ToHealth, Julia Henschel, European Workshop 2


What is ToHealth?

Leonardo Da Vinci for

Livelong Learning Programme (LLP)

Innovationtransfer

Duration Time: 10/2013-10/2015

www.tohealth.eu

April 20, 2023ToHealth, Julia Henschel, European Workshop 3


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



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).



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.



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



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.



• 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.



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



How is the method?


• Six different modules

• Final exam

• Duration : 38-40 hours


How is the method?


• 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


How is the method?


• Previous ideas

• Objectives

• Lessons

• Teaching Unit

• ActivitiesLast session: Review,

further information, self-evaluation

Session A.1

Session A.2

Session A.3


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



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.



Timeline


1th October 2013 31th October 2015now

Analysis and definition of the training course contents

Creation and updating website

Pilot course

Course objectives

Course guide

Dissemination activities

Validated course Translation of the course

Content of modules and sessions

Configuration of the multi-language e-learning platform

Questionnaire

institute of biomechanics paracelsus medical university salzburg trauma center murnau tohealth...

Documents