Production and distribution of medical devices require certain authorization and certification. Our company cooperates with and is certified by ‘DQS Medizintechnik GmbH/FFM’ according to DIN EN ISO 13485:2016.
High quality service is very important to us, which is why all processes relevant for our production are validated and according to current guideline requirements.
Since we have a lot of experience in the field of quality management and regulatory affairs, we are happy to support our customers with questions regarding authorization and certification.
Person Responsible for Regulatory Compliance (PRRC) according Article 15 of MDR 2017/745 (EU)
Phone: +49 (0) 171 695 43 17