Quality standards

European guidelines
Wij zijn EN ISO 13485:2016 gecertificeerd, waarmee we als organisatie aantonen medische hulpmiddelen en aanverwante diensten te kunnen leveren die constant voldoen aan Europese regelgeving en de wensen van de klant. De BSI Group (British Standards Institution) diende als de accreditatie-instantie voor de certificering.
We are EN ISO 13485:2016 certified by which we demonstrate our ability to provide medical devices and related services that consistently meet customer and European regulatory requirements applicable to medical devices and related services.
Our company is also certified under the BRC Global Standard Consumer Goods, Issue 3, Grade A standard according to which we meet the specific requirements for a quality management system.
To keep up to date in terms of quality, certification and standardisation, the following websites support our level of expertise.