Safety Studies

Medical equipment, cosmetics, raw materials, OTCs, and other consumer goods are all subjected to safety testing at CMDC Labs. When used under typical or anticipated circumstances, these items must be safe for human health once they are on the market. To do this, specific tests are run to protect both the manufacturer and the consumer. Therefore, in full accordance with current laws, CMDC Labs conducts initial in-vitro testing and afterwards confirms the tolerability through in-vivo investigations on healthy volunteers. In-vitro safety testing is carried out on particular cell lines and in-vitro recreated human tissue by the Cell Biology and Toxicology Laboratory at CMDC Labs.

In-vitro safety testing offered by CMDC Labs:

  • Cytotoxicity testing, performed in accordance with the UNI EN ISO 10993-5 standard for medical equipment.
  • Eye corrosion testing: “fluorescein leakage” (OECD 460).
  • Eye irritation testing: “monolayer cells and 3D reconstructed corneal epithelium” (OECD 439).
  • Skin irritation testing: “monolayer cells and in-vitro reconstructed epithelia of different origin” (OECD 435).
  • Skin corrosion testing: “percutaneous absorption testing” (OECD 428).
  • Skin sensitization testing: “THP-1, dendritic cells”; Photo Ames testing: mutagenesis (OECD 471).
  • In-vitro carcinogenesis testing: Balb/3T3 – B.21 method, Annex V, Directive 67/548/EEC.
  •  Ecotoxicology testing: Daphnia Magna (OECD 202) and seaweeds (OECD 201).

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costs and expert support from research to rollout.

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