Registration of Medical Devices:

  • Assessment of biocidal effectiveness on the basis of the available literature
  • Testing and giving opinions on finished products
  • Analyzes of the competition and the market
  • Clinical assessments
  • Risk assessments, comparative analyzes
  • Support in the full product registration process

Tests:

  • Tablet and substance tests – mechanical strength of tablets, disintegration time, grain size sieve analysis, pharmaceutical availability tests (basket, paddle, flow), rheological tests, texture analysis, adhesion, cohesion, hardness, spreadability, etc.
  • Performing expert opinions in the field of composition formulation and its stability in various temperature and humidity combinations
  • Comparative research on medical devices, interpretation of differences between products for a design or marketing purpose
  • Rheological tests including advanced viscosity measurements, such as measurement of the structural viscosity of the product at low and high shear rates, preparation of flow curves, viscosity curves, evaluation of thixotropy and yield point values
  • Texturometric tests including the assessment of hardness, spreadability, adhesion and cohesion of drug and cosmetic forms applied to the skin and mucous membranes
  • Conducting standardized, in vivo and in vitro tests, biological evaluation of medical devices based on test procedures:
    • PN-EN ISO 10993: 10993-2: 2006 (handling of animals);
    • PN-EN ISO 10993-3: 2009 (genotoxicity, carcinogenicity and reproductive toxicity);
    • PN-EN ISO 10993-5: 2009 (cytotoxicity);
    • PN-EN ISO 10993-6: 2009 (implantations);
    • PN-EN ISO 10993-10: 2011 (irritating and sensitizing effects);
    • PN-EN ISO 10993-11: 2009 (systemic toxicity).
miernik
Łukasz Miernik
Department of Technology Transfer - Innovation Broker
Phone: +48 502 447 575
Ta strona wykorzystuje pliki cookies. Korzystanie z witryny bez zmiany ustawień Twojej przeglądarki oznacza, że będą one umieszczane w Twoim urządzeniu końcowym.