- About us
The accredited testing laboratory HygCen Germany GmbH was founded on March 7, 1996 by Prof. Dr. med. Heinz-Peter Werner as a medical specialist in hygiene based on decades of practical experience and knowledge of the real and unsecured problems of infection prevention. On July 1st, 2013, Dr. med. univ. Sebastian Werner also as a medical specialist in hygiene, took on the professional and entrepreneurial succession in the family business in the second generation.
Since the first day, HygCen Germany has been improving healthcare product quality worldwide for the protection of patients and users. Our employees test whether your medical devices are biologically harmless. In the entire testing process, we check with sound methodology, according to all common standards and always without animal experiments. The test methods used by us are regularly recognized and accredited by ZLG and DAkkS. We cultivate an eye-to-eye relationship with our clients and with each other as a team.
Together we accompany you with our quality assurance tests from the first product idea to the final market approval and beyond. Just contact us via our form.
The accredited and accredited testing laboratory HygCen Germany works according to national, European and international standards. These standards are dependent on technical progress and always new issues that arise in industry, hospitals and by product users. The individual states and institutions regularly update the legal requirements so that HygCen has to react swiftly to the new test specifications. We counter this with high professional competence and lean structures. In this way, we have the right tests ready for you for every relevant policy change. If necessary, we also develop individual test methods according to your specifications and needs in accordance with the latest state of science and technology.
Our current accreditations can be downloaded below:
Test laboratories based in Germany must be accredited according to EN ISO / IEC 17025. Since 2010, the German Accreditation Body (DAkks) has been responsible for this. It monitors certification bodies and already accredited laboratories and orders new accreditations - but not with regard to the Medical Device Directive 93/42 / EEC.
Medical laboratory testing laboratories must demonstrate that they also meet the minimum requirements of 93/42 / EEC. In 2010, the legislator introduced the term "recognition" in the Medical Devices Act in § 15 (5). Testing laboratories are therefore obliged to provide proof of recognition by national authorities in addition to accreditation. In Germany, only the Central Office of the German Federal Government for Health Protection of Medicinal Products and Medical Devices (ZLG) may award this recognition. The ZLG works again on the basis of the accreditation of the DAkkS according to EN ISO / IEC 17025.
The Notified Bodies are state authorized bodies that supervise product manufacturers on how to have medical devices - depending on the risk class - tested correctly according to the specifications of accredited test laboratories. Medical device manufacturers can then contact any Notified Body designated for the required procedure and product category. The ZLG is responsible for the designation and monitoring of Notified Bodies in Germany.
Our goal is to continuously improve patient and user safety worldwide through precise quality assurance tests for products that are used on humans or animals (medical products, biocides, etc.).
"To be human means to be responsible."
The basis of medical action is the care for the health of the directly or indirectly entrusted patient. Every laboratory test by the independent HygCen test laboratory indirectly represents medical action on the patient. It is therefore the responsibility of each individual HygCen employee to always work towards the highest precision of his results.
HygCen offers you high-quality, long-term benefits that increase user benefit and patient safety.
Every product that you have tested by us receives our test and quality seal. Provided, of course, that your product meets all defined minimum requirements and specifications. This always includes the latest state of science and technology. You can use our award for your marketing activities and thus strengthen the trust of your clients.
The testing laboratory HygCen is internationally known and enjoys high professional recognition. When do your products benefit from the quality seal of the HygCen Germany GmbH?
Mit unseren Hilfsprojekten möchten wir soziale Verantwortung übernehmen und gleichzeitig Danke sagen. Dazu unterstützen wir regionale Projekte aus unterschiedlichen Bereichen und versuchen dort Hilfe zu leisten, wo sie benötigt wird. Wir unterstützen beispielsweise die tiergestützte Therapie mit Alpakas der Diakonie Grevesmühlen, die Schweriner Tafel und sind Mitglied in der Klima Allianz.