Doctors and medical professionals deal with sophisticated medical products on an everyday basis. Under European Community guidelines for medical products, manufacturers whose products have a high-risk classification must establish a link with a "Notified Body". This can be achieved through product testing and/or auditing of the manufacturer's quality management system.
TÜV Rheinland Product Safety GmbH is such a "Notified Body" for all medical products. It certifies products and QM systems for the European Market, and also serves as Certification Body for non-European countries.
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