Testing laboratory ASSESS-MED – Service Center for the Assessment of Medical Devices

The ASSESS-MED lab is part of the Department of Extracorporeal Therapy Systems of Fraunhofer IZI. The lab offers standardized, industry-focused research in the field of blood purification to support faster transfer of new technologies into the market.

The lab performs manufacture-independent testing of blood purification devices like dialyzers, filters, adsorbers and is prepared to assess medical devices according to DIN EN ISO 8637-1:2020.

Furthermore, a broad range of research questions can be addressed in close collaboration with additional facilities of the Fraunhofer Institute. The core competences of this team are complemented by close links to the University Medicine Rostock, especially the Section of Nephrology.


Standard-compliant measurement of performance parameters of dialyzers:

  • Clearance
  • Sieving coefficient
  • Ultrafiltration coefficient

Testing capabilities:

  • Endotoxin retention
  • Adsorber performance
  • Customized toxin removal panels
  • All types of test fluids
  • Extensive in-house diagnostics
  • Accelerated aging

In vitro biocompatibility testing:

  • Cytotoxicity analyses according to DIN EN ISO 10993-5
  • Hemocompatibility
  • Eluted substances


The laboratory has implemented a QMS according to ISO/IEC 17025:2018-03. An application for accreditation at the Deutsche Akkreditierungsstelle (DAkkS) is currently in preparation.

Project background

Before medical devices can be developed, produced and distributed on the market, special requirements first have to be met. Strict regulatory demands are placed on medical devices in order to transfer new therapeutic approaches or innovative products into clinical application and exploit them commercially. These requirements help ensure optimal product and patient safety. European conformity (CE) often implies high costs for companies, which is why experienced external experts, though not usually research institutes, are regularly called upon to verify that these requirements have been met (in the form of CE marking).

Thanks to the close collaboration between engineers, scientists and medical practitioners at Rostock's Department of Extracorporeal Therapy Systems, stretching back decades in some cases, the unit has the respective expertise, as seen in particular in the development and testing of new blood purification procedures and products right over to their successful market launch.

Project aims and vision

The basic idea behind the submitted project is to create a central facility for all companies and institutes that develop and produce medical devices, particularly in the field of blood purification, both on a regional and national level. Cost-intensive resources such as a certified test laboratory with qualified staff can be used by companies as an external service as and when required. Having a suitably accredited test laboratory on hand makes things a lot easier for the manufacturer as they work towards placing their product on the market. The project aims to establish a specialized, independent facility for assessing medical devices for blood purification and create the bases for its economic operation following start-up funding. The goal here is to become accredited as a test laboratory for medical devices by the German accreditation body (DAkkS). There is also a strong possibility that a spin-off can be founded once the funding period has expired.

The project is being funded using means provided by the European Union made available through the European Regional Development Fund (ERDF) and the Ministry for Economic Affairs, Labor and Health of Mecklenburg-West Pomerania

Funding reference number: GW-21-0001
(Previously funded under reference number: GW-19-0001.)

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