GENEESS tools

In the GENEESS project DSP Valley and imec developed tools for SMEs and starters who want to design active medical devices with nano-electronics for the EU market. A guideline on Best Practices for Electronics in Medical Devices was written as well as a toolkit on active medical devices aiming at SMEs and starters.
With these tools DSP Valley and imec want to stimulate companies to start activities in the medical technology.

Best Practices for Electronics in Medical Devices - Guideline

The guideline covers the basics about the 2 major regulatory systems. The Medical Device Directives with CE marking in Europe, and the FDA regulatory system (Center for Devices and Radiological Health) in the USA.
Items you can find in the guideline are:

  • Basic elements of regulatory requirements for medical devices.
  • The realization of medical devices containing electronics.
  • Basic elements of project management for active medical devices.
  • Basic elements of Design-for-X: Design-for-Test, Design-for-Reliability, Design-for-RoHS, etc.
  • Basic overview of biocompatibility, bio stability and sterility for medical devices.
  • Design & testing of active medical devices.

A first version of the guideline was written by Maaike Op de Beeck, Filip Ponsaerts and Frederik Horemans in 2015. The revision of the ISO 13485:2016 and the upcoming conversion from Medical Device Directives (MDD) to Medical Device Regulation in the EU lead to the publication of a second version of this guideline in May 2016. You can download this updated guideline here.

Toolkit – assessing intended use & device classification

The toolkit is a web based tool to support those who develop a medical device.  The tool is an interactive guide trough the directives 93/42/EEG and 2007/47/EC.  It supports in defining the risk class to which the device will belong based on the intended use by providing a first fast evaluation of the impact of intended use (and variations of it) on the device classification, the CE marking and thus the required level of quality management system.
The toolkit is designed for SMEs and starters who want to design active medical devices with nano-electronics for the EU market. An active medical device is defined as incorporating some kind of power source. The toolkit does not cover In Vitro Diagnostic Devices (IVD) and implantable devices.
This tool will help starters in assessing the medical device by classifying it in the MDD system from class I to class III  based on the intended use. This does reflect the level of risk to the patient and care provider, the level of invasiveness and the duration of direct contact with the patient. The device classification does impact the possible routes towards CE marking and the required quality management system.
With the tool SMEs and starters can get a first fast evaluation of the impact of intended use (and variations of it) on the device classification, the CE marking and thus the required level of quality management system.

Start the toolkit here.

GENEESS Online search portal

You can find the portal here.

To gain access to the portal you will have to provide a username and password. Please contact Annelies Vandamme for these coordinates.