TU Delft
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2010/2011 Mechanical, Maritime and Materials Engineering Master Biomedical Engineering
Medical Instruments B: Quality Assurance in Design
Responsible Instructor
Name E-mail
Dr.ir. G.J.M. Tuijthof    G.J.M.Tuijthof@tudelft.nl
Name E-mail
Prof.dr. J. Dankelman    J.Dankelman@tudelft.nl
Dr. J.J. van den Dobbelsteen    J.J.vandenDobbelsteen@tudelft.nl
Contact Hours / Week x/x/x/x
Education Period
Start Education
Exam Period
Course Language
Course Contents
A prototype of a new instrument has a long way before entering the market. Apart from assessing its commercial value, medical instruments need to be produced in accordance with regulatory guidelines before clinical evaluation can take place. In the course Quality Assurance in Design students analyze designs of medical instruments (prototypes and/or technical drawings) based on the NEN-ISO 13485 for medical devices and propose a roadmap that leads to a successful clinical evaluation. In this roadmap items such as material selection, production, cleanliness, sterilization, certification and risk management will be addressed.
Study Goals
At the end of the course the student must be able to:
Describe required adjustments for a medical instrument prototype to comply with regulatory guidelines
Perform a risk analysis for a medical instrument prototype (e.g. by applying Failure Mode Effect Analysis, etc.)
Education Method
At the start of the course, lectures familiarize the students with the regulatory guidelines based on examples. Students will select a test case from the prototypes that have been developed within the department. The students work in groups, where each student is responsible for one part of setting up a road map (e.g. material selection). Close collaboration is required as all topics are related. In the remainder contact hours students are expected to present and discuss their progress. The course is finalized with a presentation of the roadmap and a report.
Final presentation (20%) and report (80%)
3mE Department Biomechanical Engineering