For Cavex, quality is the key word in both our production processes and our final products. Therefore, we are strongly committed to complying with the high requirements arising from the Medical Device Regulation (EU) 2017/745 (MDR).
To maintain our high quality standards and stay certified, Cavex Holland BV is audited annually by the notified body TÜV Rheinland. In the coming year, our company will be re-certified in accordance with EN ISO 9001:2015, EN ISO 13485:2016 / A11:2021, and the Medical Device Regulation (EU) 2017/745.
Apart from 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 comply with GMP – ISO 22716:2007 for cosmetics and EC Regulation 1223/2009 on cosmetic products. This certification is issued by an independent accredited certification body.
In conclusion, we can proudly state that the Cavex Quality System complies with all relevant standards and regulations. The relevant certificates are available upon request or via the websites of TÜV Rheinland and the respective authorities.
