Bernafon

At Bernafon, quality hearing solutions are developed in compliance with international regulations, directives, and requirements. Below, find a brief summary of some official requirements and certifications that all Bernafon products fulfill (n.b. the paragraph is neither final nor comprehensive). In Europe, the Bernafon company is ISO9001 und ISO13485 certified. All Bernafon products are compliant with Europe's Medical Device Directive (93/42/EEC) and are therefore CE marked. In North America, Bernafon products are compliant with regulations issued by the US Food and Drug Administration (FDA); and in Australia, Bernafon products comply with regulations issued by the Australian Therapeutic Goods Administration (TGA).