For Cavex “quality” is the keyword for both our production processes, as well as our final products. Therefore we are very committed to comply with the high requirements arising from the new Medical Device Regulation 2017/745, also known as “MDR”.
To enforce our high quality standards we are audited early by notified body “TÜV Rheinland”. The 2022 audit has been a special one due to it being the first certification audit in accordance with the MDR. We are proud to announce that Cavex Holland BV has been found to fully comply with the MDR legislation for all Class I and Class IIa medical devices.
Apart form the MDR, we are also certified according to ISO 9001 and ISO 13485 including supplementary requirements according to MHLW 169 and TCP. For the production of our oral care products we are in compliance with the ISO22716:2007 GMP for cosmetics and the EC Regulation 1223/2009 on cosmectics.
In conclusion we can proudly state that the Cavex Quality System is in compliance with all the relevant specifications. The various certificates are available below, or directly from the websites of TÜV Rheinland (www.tuv.com) and the Food and Drug Administration (www.fda.gov).