07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
Product category: Technical equipment management, test houses / certification bodies
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.
”mdc medical device certification“ stands for safety and quality in the sensitive field of medical devices and healthcare.
Our experienced staff of more than 60 employees and 70 external auditors and experts ensure knowledge and experience in the relevant key technologies of medical device manufacturing and testing. Due to their contributions we not only belong to the major Notified Bodies for medical devices and in-vitro diagnostic devices in Germany, but throughout Europe and to the major quality system registrars in our sector. The comprehensive knowledge of our staff enables us to offer certification of a wide range of products and of companies of all sizes.
More than 2000 clients in more than 30 countries rely on our knowledge and our services. Their clients and business partners also rely on our certificates and the devices, which are CE marked in combination with our identification number “0483”.
Our activity is an important contribution to safety of patients and users of medical devices and should, in addition, encourage the awareness for quality in the enterprises.
Competence, independence, objectivity, neutrality and confidentiality are the cornerstones of our activities.