Van Straten Medical is both ISO 9001 as well as ISO 13485 certified.
All products supplied by Van Straten Medical meet the CE directive Medical Devices, nr 93/42/EEG.
Beside the CE mark our products are registered and approved by national regulatory authorities in multiple countries, including FDA and TGA.
According to the Notified Body it could be demonstrated during the audits that the quality assurance system for the design, manufacturing, distribution and sales of medical devices and dedicated equipment used in the operating theatre, oral implantology and orthopaedics according to DIN EN ISO 9001:2008 and 13485 has been demonstrated.
The Van Straten Medical Instrument Repair Center is also ISO 9001 and ISO 13485 certified and approved as "approved repair center". All services are DIN Norm compliant.
