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Cavex Holland BV
Certified since 1994
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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 cooperate with TUV Rheinland, 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. The head office of TUV Rheinland is in Cologne, Germany but it has global service offices in more then 50 countries.
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In 2006, TUV Rheinland performed a certification audit for Cavex and took over the responsibilities of the former notified body. During this certification audit the quality system of Cavex Holland B.V. was thoroughly inspected in which no significant deviations were observed.
TUV Rheinland performed the inspections according to ISO9001:2000, ISO13485:2003 and the Medical Device Directive (93/42/EC) in order to fulfil the European legislation and to obtain the legal ability to affix the CE mark label on the products. Besides, the Cavex QMS was inspected for specific legislation requirements in accordance with the Technical Cooperation Programme between the EU Notified Body Partners and DOH Designated Auditing Authorities for Taiwan (TCP Cover Letter).
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This year again, Cavex and TUV Rheinland extended the audit. The additional specifications as defined in the ISO13485:2003 under CMDCAS for Canada and the MHLW ordinance no.169 based on Pharmaceutical Act Legislation for Japan were included. For both, countries all the requirements were met and certificates / reports were obtained.
In the USA the Food and Drug Administration (FDA) is responsible for regulation of medical devices. The manufacturer has to fulfil the specifications of Quality System Regulations 1996:21 CFR§820, followed by a so-called 510k application for every Medical Device to be registered. Cavex Holland B.V. as a manufacturer of medical devices and most of the Cavex product assortment is successful registered by the FDA. Detailed information on registered manufacturers, registered medical devices and medical device reporting (vigilance) can be found on the official FDA website
As an extra service additional copies of the certificates can be retrieved from the links below or directly from the independent TUV Rheinland website: www.TUV.com
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