It is our mission to act as a specialist in the sector of medical devices, healthcare and related areas.
Our range of services in the field of assessment and certification has always been strictly oriented to our clients’ needs and continues to expand. The primary activities focus on the assessment and certification of quality systems in relation with the mandatory CE marking of medical devices or with the certification according to quality system standards on a voluntary basis.
In the area of CE marking we cover a wide range of devices under Directives 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic devices.
Various quality system standards are the basis for our certification services. Besides EN ISO 9001, which covers a wide scope of activities in all areas, we offer certification according to EN ISO 13485, which is specifically intended to be used in the field of medical devices. Manufacturers of primary packaging materials or primary packaging components for pharmaceuticals can be certified according to EN ISO 15378.
We are one of the few European Notified Bodies, whose audits of medical device manufacturers based in Europe, are recognized under the Technical Cooperation Program (TCP) in Taiwan. Audits for medical device companies seeking approval in Canada of Japan can be offered in cooperation with adequate partners.
Furthermore, we offer assessment and certification of health care institutions, doctors‘ offices and providers of other health care supplies according to special German requirements.
The range of our certification services is supported by the performance of public seminars for our clients and other interested persons. Here they can extend and update their knowledge in the area of quality management and regulatory affairs.