Also in 2020 we successfully carried out a recertification audit of our quality management system in accordance with EN ISO 13485: 2016 and the Directive 93/42/EEC. Another surveillance audit according to the Medical Device Single Audit Program (MDSAP) guideline was also successfully completed. This serves as proof of compliance with the ISO 13485: 2016 standards and with the legal requirements for medical products in the USA, Canada and Australia.

For more information on our quality management:


Photo: Markus Winkler on Unsplash