EN ISO 13485:2016
MedFact is certified according to EN ISO 13485:2016.
We are happy to inform all our customers, that the transfer to the new standard EN ISO 13485:2016 was concluded successfully in February 2019.
Together with the change of standard MedFact transferred to a new scope:
"Design, development and manufacture of medical devices especially catheters and tubing sets, for cardiovascular/endovascular applications, electrophysiology, neurology, infusion therapy, gastroenterology, gynaecology and neonatology
Providing consulting services to medical device industry"
If a copy of our certificate is needed, please contact email@example.com or use the following contact form.