QUALITY MANAGEMENT

EN ISO 13485:2016

MedFact is certified according to EN ISO 13485:2016 + AC: 2018 +A11:2021.

We are happy to inform all our customers, that the re-certification according EN ISO 13485:2016 was concluded successfully in March 2022. In October 2022 the new certificate with an updated scope, adding "Regulatory advice in the aforementioned product areas" was issued.
The following scope is now explicitly valid for both our locations:

"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

Regulatory advice in the aforementioned areas as well as study planning and implementation in the aforementioned areas on clinical aspects"

If a copy of our certificate is needed, please contact office@medfact.eu or use the following contact form.