Our certifications and standardized processes.
Certified solutions driven by strong values.
MDR: Class IIa
Our technology is certified as a class IIa medical device under EU MDR. This means that an independent Notified Body, in our case TÜV Süd, verifies our compliance with norms and standards in annual audits.
QMS: ISO 13485
The safety of our products is a top priority, therefore all key processes in the company are certified according to ISO 13485:2016. This quality management system ensures that the highest standards of performance and safety are reliably met.
ISMS: ISO 27001
We deploy various vulnerability scans into the development pipelines and product environments. Found vulnerabilities are reported to monitoring systems, and appropriate remediation actions are taken.
Declaration of Conformity
The Declaration of Conformity is a required document in which we declare that the products described comply with the applicable Regulation (EU) 2017/745 on medical devices as well as relevant standards.
Standardized processes and standards.
Being a medical device manufacturer, we have to adhere to a large number of regulatory requirements, which are ensured by compliance with standards. In addition to the ISO 13485-compliant quality management system, we meet the requirements of the following relevant standards, directives, and laws:
- Medical Devices Regulation (MDR) 2017/745
- Medical Devices Act and relevant regulations
- EN ISO 14971:2019
- EN 62304:2006 + A1:2015
- EN 62366-1:2015
- EN 82304-1:2016
In addition to this, we comply with all local regulations in the countries where we market our product.