Tools & Downloads


Explore detailed information about the Engineering step of the innovation circle. Discover short articles, relevant websites, and downloadable hand-outs. Click the heart icon to save these components to your personal page.

Quality Management System

To develop your medical device you have to make sure you document all steps in your process. If you want to bring it to market in the US and you need an FDA clearance it is even more of an issue: not documented is not done. So you need a quality management system (QMS) and a procedure for development. There are companies that can do this for you. You may find them at the tile. If you need or want to do it yourself, make sure you take care of documentation.

Webinar 'Getting started with patents'

In the webinar Getting started with patents, patent attorney Henri van Kalkeren takes you through the most important topics about patents, so you can be more profitable with your innovation.

Webinar 'Patent database and research'

In the webinar Patent database and research, patent attorney Marijke Westra explains how you can use existing patent information for your innovation or business strategy.

Flowchart: Is your software a Medical Device?

MDR IVDR (Dutch)

Assess through the flowchart whether you require a CE certificate for the distribution of your software and if seeking certification from a notified body is necessary

Medical Device Design Process (Gilman et al., 2009)

Medical Device Directive (in vitro diagnostic)

You are required to comply with the Medical Device Directive (MDD) in order to discover the necessary steps you should take. Similarly you can find the In Vitro Diagnostic devices and repealing Directive (IVDR).

The Design of Medical Devices (Tamsin & Bach, 2014)