The medical devices come in direct contact with skin or body fluids, while addressing varied health requirements of a patient. At times, these may result in unintended complications if the materials used cause a biological reaction in patients. It therefore becomes essential to evaluate these for biological risk assessment to ensure that they do not cause any adverse biological reaction to the patient, and are devoid of any toxic, physiological, immunological or mutagenic effects. Biocompatibility testing forms a critical part of the regulatory process to ensure that these are medically safe for use.
At VIMTA, we offer complete range of biocompatibility testing for medical devices, from initial screening of new materials to product release testing, periodic audit testing, and non-clinical or pre-market safety evaluations, in accordance with current US-FDA and international standards. Our biocompatibility testing panel addresses the testing needs of both small scale and large scale manufacturers. Our biocompatibility capabilities include testing for surface devices coming in close contact with intact skin, mucous membranes and breached or compromised surfaces, testing for externally communicating devices and implants.
Our service portfolio includes testing for
- Irritation and Intra-cutaneous Reactivity
- Skin Sensitization
- Sub-acute and Sub-chronic Systemic Toxicity
- Sub-acute and Sub-chronic Implantation Studies
- Hemocompatibility Studies
- Genetic Toxicity
- Reproductive Toxicity