Due to an audit realized by the German company “MEDCERT Z.P.M. GmbH” to our production unit, we have been able to prove that our quality management system satisfies all requirements. These requirements are:
- EN ISO 13485
- Anexa II a Directivei 93/ 42/ EEC
- Anexa V a Directivei 93/ 42/ EEC.
- ISO 14001
- ISO 9001