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Re-certification by TUV Rheinland 0197New: Quadrant Universal LC, with Fluorescence pigmentA new, broader look at the factor Shine
Cavex Holland BV
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| Already in 1994, Cavex Holland implemented a full quality management system in order to comply with the provisions of the Medical Device Directive (93/42EC)
To maintain the validity of the ISO9001, ISO13485 and CE-mark certificates many external audits were performed over the years. Official members of different competent authorities and our notified body showed time after time the adequate performance of the Cavex quality management system. Today, we are facing a continuous change in the world-wide situation of the registration requirements. Modernisation in registration departments and local legislation result in more and more requests for additional documentation from the different countries. To comply with all these requirements now and in the future it is necessary to have the assistance of a reliable and competent notified body. Therefore, Cavex decided to change to a notified body who is not only authorised for the single CE mark certification in Europe but is recognised and accreditated by most authorities in the world. This new notified body for Cavex is TUV Rheinland with head office in Cologne, Germany and global service offices in 50 countries. | |
| In February 2006, TUV Rheinland performed a re-certification audit for Cavex and
took over the responsibilities of the former notified body. During the re-certification
audit the quality system of Cavex Holland B.V. was thoroughly inspected in which no
significant deviations were observed. Unfortunately, the change of notified body has also a disadvantage. The identification number for the new notified body has to be adapted for all packaging materials of the Class IIa products: amalgam, cement, temporary, composite&bonding. To obtain a gradual but fast change, avoiding unnecessary costs, we have formed a project team. For our customers the product quality or product packaging shall not change. Only the identification number for TUV Rheinland 0197 will appear on all Class IIa products |
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To show that Cavex Holland BV has performed the re-certification and that the products fulfil all specifications of the Medical Device Directive (93/42/EEC) we send you hereby copies of the following certificates:
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