There are lots of names for the package inserts and instructions for use that, once unfolded, refuse to fit back into the box.
The regulations for instructions for use of medical devices are very strict.
As a Swiss-Medtech member, we are very familiar with these regulations and guarantee the highest quality with validated production processes according to ISO 13485:2016.
No matter how small or thin a package insert has to be: With our expertise and our machines – specially equipped for the production of package inserts – we can solve any seemingly big problem in no time at all.
Of course, the above industries also benefit from our services in the area of instructions for use or package inserts.
Whether it’s a small-folded leaflet or a multi-page booklet: we put the information about your product into a regulatory-compliant form.
Thanks to our many years of experience and early specialization in package inserts and instructions for use, we are specialists in their production.
We take care of the design, the right format and the right paper quality and meet all the necessary requirements in terms of production technology - including finishing.
For certain medical devices, it is permitted to provide electronic instructions for use (eIFU) instead of printed instructions for use.
smartifu supports you as a manufacturer to realise this change and to comply with applicable regulations.