In our modern and efficient production facility with our enthusiastic group of colleagues we strive continually to improve the level of quality of our products and services.
Cavex Holland B.V is each year audited by the notified body TÜV Rheinland on our certificates of ISO 9001, ISO 13485 and Medical Device Directive 93/42/EEC + 2007/47/EC including supplementary requirements according to MHLW 169 and TCP
In 2018 TÜV performed in addition to our standard certificates an upgrade audit due to the changes in the ISO13485 standard, ISO1348:2012 changed into ISO13485:2016. We passed the ISO 13485:2016 upgrade audit.
We are also in compliance with the ISO22716:2007 GMP for cosmetics and the Cosmetic Directive 76/768/EEC, all required for the production of our Cavex Bite&White products.
Proudly we can state that the Quality System is in compliance with all the relevant specifications. The certificates are available at the Cavex website (see below) or directly from the independent TÜV Rheinland website: www.TUV.com
And FDA website: www.FDA.gov