Quality Control at Ofa Bamberg
CE.Marking – our compression stockings comply with European Directives.
The CE- Marking serves as a “passport“ for the European internal market and allows Ofa products to circulate freely in the European economic area. It indicates compliance with the requirements for medical products in accordance with the European Directive 93/42 EEC and the German Medical Devices Act (MPG).
DIN EN ISO 9001 / 13485. We use process oriented quality management.
We have since 1995, as the first in our sector, been certified in accordance with the Quality Management System DIN EN ISO 9001 / DIN EN 46001 (today DIN EN ISO 13485). This certificate verifies and documents process-oriented operations and the optimisation of operational structures within our company. The continuous improvement of processes is guaranteed on the basis of regular audits.