With the introduction of the new Medical Device Regulation 2017/745 also known as MDR, we have been working hard to meet these requirements. Cavex stands for quality and the premium products we produce therefore meet the highest possible quality and safety standards.
Medical Device Regulation
The purpose of the MDR is to ensure the smooth functioning of the internal market for medical devices, based on a high level of protection for the health of patients and users, and taking into account the small and medium-sized enterprises (SMEs) operating in this sector. At the same time, this Regulation sets high quality and safety requirements for medical devices in order to address common safety concerns regarding such products.
Audit by TÜV Rheinland
Every year Cavex undergoes an audit by the independent TÜV Rheinland and this year the primary focus was the MDR certification. After an extensive quality inspection over several days, we can proudly announce that from now on we are fully MDR certified for medical devices classes I and IIa.
ISO certification
Next to the MDR Cavex Holland BV is still certified according to ISO 9001 and ISO 13485 including supplementary requirements according to MHLW 169 and TCP. In addition, we also comply with the ISO22716:2007 GMP for cosmetics and the Cosmetics Directive 76/768/EEC. These are required for the production of our Cavex Bite&White products.
More information
All our certifications are available on our website. You can also find them on the websites of TÜV Rheinland and The U.S. Food and Drug Administration.
With these certifications, we ensure that you can always rely on Cavex for products that meet the highest quality and safety requirements.
Our products
Would you like to know more about our products? Click here for our full product range or feel free to contact us.