Our work and products embody special care and responsibility, and as such, up-to-date qualifications, certificates, and verifications are a matter of course for us.
Medizintechnik Promedt GmbH is certified according to DIN EN ISO 13485:2016 and ISO 13485:2016 MDSAP for the contry-specific requirements of Australia, Brasil and Canada. The product certification is carried out in accordance with Regulation (EU) 2017/745 (MDR) and partly via a notified body confirmation letter within the framework of Regulation (EU) 2023/607.