In the global effort to help the healthcare professionals in the fight against the Covid pandemic, we are providing the following documents to help manufacturers that are not familiar with medical devices to properly document their work to help them in their product development and achieving compliance.

These templates are derived from our technical file documentation and include some reference to guidances (mostly applicable in Belgium) for devices and accessories to answer to hospital products shortage. 

Download here:

Technical File template_3D_COVID
Technical File template_Surgical Mask_COVID

DISCLAIMER: the use of these templates does not guarantee full compliance to applicable standards and directives and does allow as such the products to bare a CE mark.

Photo credits: CDC on Unsplash