EN ISO 13485:2016
MedFact is certified according to EN ISO 13485:2016.
We are happy to inform all our customers, that the re-certification according EN ISO 13485:2016 was concluded successfully in March 2022.
The following scope is now explicitly valid for our secondary location in Weiler Straße:
"Design, development and manufacture of medical devices especially products for intravascular use, as well as catheters and tubing sets for cardiovascular/endovascular applications, electrophysiology, neurology, infusion therapy, gastroenterology, gynaecology and neonatology"
If a copy of our certificate is needed, please contact firstname.lastname@example.org or use the following contact form.