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Medical Devices ? In Trustworthy Hands
Are you looking for a competent partner to lend a helping hand as you face the challenges and markets of the future? Then we are just what you need. Precisely Right.
You as a manufacturer bear a heavy responsibility, especially for medical devices. The product must not only deliver the best possible benefit but also fulfill each and every statutory requirement. Our neutral statement is your safeguard.
As an internationally recognized notified body we are your point of contact for the following:
- Conformity assessment procedures
- Quality management systems
- Tests of medical devices
Medical device testing according to the 2012 requirements
TÜV Rheinland InterCert Ltd. is prepared and ready for electrical medical equipment testing under the requirements of the standard IEC EN 60601edition3 which will become mandatory on June 1, 2012.
The scope of the standard has been significantly modified and extended to product types which were not covered by the IEC EN 60601 standard previously. Furthermore, the standard requires risk management procedure which should cover the whole life cycle of the device.
TÜV Rheinland offers partnership to the manufacturers which does not limited to the certification of conformity. We are ready to join to the development process and support our clients with consultancy and pre-examinations.
In the framework of an international cooperation TÜV Rheinland intends to strenghten of the medical examination area in the near future.
Contact: Zsolt Bajnok zsolt.bajnok@hu.tuv.com; +36 1 461 1100
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With a presence in over 60 countries we know and maintain a watching brief on the constantly changing requirements in the most important international markets. That is your key to swift and uncomplicated market access – all over the world!
Challenge us. We are at your service!