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Medical products
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 "Designated Office". This can be achieved through product testing and/or auditing of the manufacturer's quality management system.
Also active implantable medical devices must be designed and manufactured such that when implanted under the conditions and for the purposes laid down, they will not compromise the clinical condition or safety of patients. They must not pose any risk to the person implanting them or where applicable, to any other persons.
TÜV Rheinland / Berlin-Brandenburg is such a Designated Office for all medical products. It certifies products and QM systems for the European Market, and also serves as Certification Body for non-European countries.
