With our ultra-modern and efficient production facility and enthusiastic group of colleagues we strive to continually improve the level of quality and improve the quality of our products and services.
Each year Cavex Holland B.V is audited by the notified body TÜV Rheinland.
This year TÜV performed a surveillance audit following ISO9001:2008, ISO13485:2012 and Medical Device Directive 93/42/EEC. In addition to this surveillance audit we also had a re-certification audit on CMDCAS.
We passed both surveillance and re-certification audit.
We are also in compliance with the ISO22716:2007 GMP for cosmetics and the Cosmetic Directive 76/768/EEC required for the production of Cavex Bite&White products which are considered Cosmetics.
Next to a TÜV audit we had an FDA inspection. The inspection included, Management, Design control, Facility & Equipment Controls, Production & Process Controls, Records/Documents/Change Controls, Material Controls and Corrective & Preventive Actions (CAPA).
The inspector concluded that the QMS is in compliance with the US Medical Device law.
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