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Department Drug and Device Testing

  1. Center for Biomedical Research and Translational Surgery
  2. Our Departments
  3. Department Drug and Device Testing

The Center for Biomedical Research and Translational Surgery has a long standing expertise in testing new medical devices and drugs.

The available methods range from cell culture to pre-clinical animal models. This is only feasible with dedicated and experienced staff as well as state-of-the-art equipment. Based on this we are able to support our customers in the best possible way, thereby guaranteeing the successful development of their product. We are part of the medical device regulation (MDR) taskforce at the Medical University of Vienna, a pipeline for translational medicine from basic science to clinical practice.

 

Mission Statement

Our aim is to provide the finest service to our customers, deliver innovative ideas and support manufacturers of medical devices and drugs.

Biocompatibility Studies – ISO 10993

In brief, biocompatibility is the tolerance of a material with natural tissue. The ISO 10993-1: 2018 standard defines biocompatibility as the „ability of a medical device or material to function with an appropriate host response in a given application“. The first step in biocompatibility studies is usually an in vitro screening by testing the cytotoxic effect of the test item (medical drug / medical device). Once the in vitro tests are completed in vivo tests has to be performed. The in vivo test design strongly depends on the final application of the medical drug or medical device. They can range from skin irritation tests, sensitization tests, implantation tests to systemic toxicity tests.
The right strategy and careful planned experimental design is crucial for successful in vivo tests. Based on the test results, new active compunds or materials used for implantation can be approved our authorities.

Good Laboratory Practice (GLP)

GLP is a quality assurance system that regulates the planning, execution and monitoring of non-clinical safety studies. The strict standards were originally introduced in order to make the results of different laboratories nationally and internationally comparable and recognized. The conduct of studies, their documentation and the archiving of data are strictly regulated. The GLP quality system also sets strict standards for technical equipment as well as for the training and education of staff. Compliance with GLP programs are controlled at international level by the OECD (Organisation for Economic Co-operation and Development), at national level laboratories are inspected by governmental authorities such as the AGES (Agentur für Gesundheit und Ernährungssicherheit). This certification guarantees the fulfilment of quality standards according to the requirements of the EMA (European Medicines Agency), but also the FDA (Food & Drug Administration), as the equivalent US authority.

Certification of compliance with GLP

Our facility is considered as beeing capable to perform non-clinical studies in the areas of expertise listed below in compliance with the OECD Principles of Good Laboratory Practice:

  • Category 2 / toxicity studies
     
  • Category 9 / other studies:
     
    • Pharmacological studies,
      Testing of medical devices
      (biological evaluation of medical devices)

Good Scientific Practice (GSP)

It is the duty of universities to promote research and they are responsible for ensuring that research projects are conducted properly, in line with scientific, ethical and legal criteria.

In order to guarantee this, universities have to establish clear rules and standards. The present „Good Scientific Practice“ – Ethics in Science and Research – Guidelines of the Medical University of Vienna have been drawn up in consideration of the latest international guidelines and approved by the University Senate. 

Please find all details concerning Good Scientific Pratice on the website of the Medical University of Vienna.

Administration