Biocompatibility & Toxicology
MDTL can assist in the development of data necessary to support the regulatory requirements of the Medical Device industry. ISO 10993 describes the general principles governing the biological evaluation of medical devices within a risk management process. The ISO 10993 guideline is generally accepted worldwide.
Biological Evaluation According to ISO 10993
MDTL offers biological studies with accredited partner labs according to the matrix of ISO 10993-1 and can also create individual customized testing strategies. Evaluation depends on the category of the medical device in accordance with the nature of the devices' use pattern and the duration of contact.
Bridging Studies
MDTL also conducts bridging studies to determine scientific background for the biological evaluation of a medical device. These studies provide essential information for assessing risks and benefits as well as achieving the ethical conduct of the planned evaluation as required by the animal welfare regulation (i.e. ISO 10993-2). Biocompatibility is evaluated through expert reports based on material and literature data, along with actual study results.
Biocompatibility Tests
|
Cytotoxicity |
|
Hemocompatibility |
In vitro assays
Biological endpoints
|
|
Irritation |
|
Functional Implantation Studies |
Soft tissue
|
|
Sensitization |
|
Local Tolerance |
Histocompatibility
|
|
Toxicity |
|
Genetic Toxicology |
|
