QUALITY MANAGEMENT

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 office@medfact.eu or use the following contact form.