On March 7, 1996, Prof. Dr. med. Heinz-Peter Werner and Dipl.-Ing. (FH) Margrit Werner founded our testing institute. Since 2013, her son Dr. med. univ. Sebastian Werner as successor is managing director of HygCen Germany. Both generations have a common idea: Over 20 years of hygiene jointly responsible!
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. Anchored in the heart of Schwerin, HygCen Germany GmbH is a member of the HygCen Group. The HygCen Group is a voluntary pan-European association of independent, accredited testing institutes and inspection bodies. 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:
Accreditation by DAkkS according to EN ISO / IEC 17025, D-PL-18818-02
Recognition according to § 15 (5) Medizinproduktegesetz by the ZLG, ZLG-AP-314.10.23
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.
The aim of HygCen Germany is to continuously improve the safety of patients and users through our quality assurance tests for products used on humans or animals (medical devices, biocides, etc.) worldwide.
Only if you, as our client and your clients, can rely on consistent quality, we can win your trust in the long term. We are convinced of that. In addition, we feel committed to patients, users and society.
Our technical experts work as neutral contact persons in national and international committees for a high reputation. We always comply with European and international standards. If these are not available or sufficient, our employees develop new, individually adapted test methods with our clients - for maximum product safety.
HygCen Germany always works impartially, independently and absolutely confidentially in accordance with the company values set.
These principles are also reflected in our vision. We commit ourselves to fulfill all tasks, analyzes and examinations according to the highest professional and qualitative standards for patients and users. This concerns an excellent methodology as well as the precise, fast and reliable order processing.
Our vision is "Quality creates trust!" For us and our clients, this means in particular: Only the responsible way is the right way to the goal!
To illustrate our vision, we like to use a metaphor from mountaineering. Just as both rope partners rely unconditionally on responsible thinking and acting when mountaineering, we at HygCen assume the responsibility of quality assurance in product safety. For and together with our clients. You can rely on it. Every employee has committed to this responsibility in our credo towards clients and colleagues.
HygCen offers you high-quality, long-term benefits that increase user benefit and patient safety.
Every product that you have tested by us or another member of the HygCen Group 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 Group?