Each module contains 3 ECTS. You choose a total of 10 modules/30 ECTS in the following module categories:
- 12-15 ECTS in technical scientific modules (TSM)
TSM modules teach profile-specific specialist skills and supplement the decentralised specialisation modules. - 9-12 ECTS in fundamental theoretical principles modules (FTP)
FTP modules deal with theoretical fundamentals such as higher mathematics, physics, information theory, chemistry, etc. They will teach more detailed, abstract scientific knowledge and help you to bridge the gap between abstraction and application that is so important for innovation. - 6-9 ECTS in context modules (CM)
CM modules will impart additional skills in areas such as technology management, business administration, communication, project management, patent law, contract law, etc.
In the module description (download pdf) you find the entire language information per module divided into the following categories:
- instruction
- documentation
- examination
The course provides an in-depth overview on all relevant aspects for successfully introducing a medical device into the market. The corresponding topics include the important tasks during the development of a medical device (prior market access) as well as after its placement on the market.
Prerequisites
This course requires knowledge about
- technical design methods
- mathematical statistics/data analysis
- basic organic chemistry
Learning Objectives
The aim of this lecture is to
- know the important medical device design principles
- know all relevant aspects for the development of a medical device with respect to a successful market placement
- understand the regulation for medical devices in Europe (MDR) and USA (FDA)
- apply current standards for (software) design, risk management, usability and/or biological aspects
Contents of Module
14 different topics related to the market access of a medical device will be presented each week as follows:
(1) From lab bench to bed side: medical device design principles.
(2) Understanding compatibility of materials according ISO 10993.
(3) Basic knowledge in microorganisms and pathogens (including ISO14644/clean room).
(4) Knowledge of cleaning and disinfection processes of medical products as well as sterilization procedures and methods. In addition, overview on the packaging of sterile products.
(5) Understanding the scientific language of medicine, the research culture as well as the ethical aspects in the context of medical devices.
(6) Knowledge of the classification of medical products and the requirements of EU-MDR and US-FDA.
(7) Insights into the quality management system EN ISO 13485:2016.
(8) Knowledge of the CE-labelling in Europe and registration procedure in the USA. Product labelling (ISO 15233) and UDI.
(9) Overview on the legal requirements on the design and construction of medical products. This includes the requirement management as well as the verification and validation of development results including the Software Life Cycle (ISO 62304).
(10) Knowledge of the legal requirements on producers of medical products in Europe and elsewhere.
(11) Introduction into the clinical testing of medical devices and basic knowledge of "good clinical practice" (including ISO 2859 and ISO 3951).
(12) Understanding the basics in the usability according EN 62366, validation of the usability.
(13) Understanding the risk management according ISO 14971 and having insights into the risk analysis.
(14) Overview on the markets, health systems and the decision makers when it comes to acquiring new medical products.
Teaching and Learning Methods
Lectures and practical work on computer
Literature
- Slides and lecture notes will be available in addition of recommended book chapters
- MDR
- EN ISO 13485:2016
- ISO 14971, 10993, 14644, 15233, 62304, 2859, 3951
- EN 62366
Download full module description
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