TÜV Rheinland AG is a privately operated testing service provider.
The corporation employs a total of 19,600 people from all seven continents. Our independent experts stand for quality and safety in efficient interplay between people, the environment, and the technology in nearly every sphere of economic and personal activity.
As an independent party, TÜV Rheinland tests technical installations, products, and services, conducts testing on behalf of companies, and supervises projects and processes for companies. All of this is done in accordance with recognized standards and both national and international legal regulations, including German und international DIN and ISO standards, as well as laws and ordinances. Furthermore, the experts at TÜV Rheinland train and certify people in a broad range of fields and industries. This is made possible by the company’s global network of authorized laboratories and testing and training centers. TÜV Rheinland employees act under the conviction that social and industrial development is not possible without technical progress. And decisive role in this process is played by the safe and responsible deployment of technical innovations, products, and systems.
In a field that is characterized by fast-moving cycles of innovation, competence and quality are important factors for success. Place your trust in the experts at TÜV Rheinland. We are a notified body authorized to inspect your medical products and in vitro diagnostics and can assist you with the right conformity assessment procedures for CE marks – meaning you can get your “driving license” for EU countries that little bit quicker. Upon request, we can also certify your quality management system in compliance with the EN ISO 13485, ISO 9001, or ISO 15378 standards.
In addition we can also carry out product tests, for example according to the standards of EN 60601 or biocompatibility.
Medical Approvals and International Market Access Services:
The EU directives on Medical Devices (93/42/EEC),Active Implantable Medical Devices (90/385/EEC) and In-Vitro-Diagnostics Medical Devices (98/79/EC)
CMDCAS (Canada), TCP (Taiwan), INMETRO (Brazil)
New Medical Device Single Audit Program (MDSAP) for USA, Canada, Brazil, Australia and Japan
Specific market approvals
Test mark example
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