Biocompatability Certification

Charlotte, NC – January 30, 2017 – GMI has completed and PASSED biocompatability testing based on FDA Good Laboratory Practice regulations. The tests were completed by an independent laboratory, on the materials that GMI uses in the repair of ultrasound transducers. The studies were conducted based on: ISO 10993-5, Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity and ISO 10993-10, Biological evaluation of medical devices – Part 10: Test for irritation and skin sensitization.

GMI submitted multiple samples for biological evaluation for the presence of cytotoxicity, irritation and skin sensitization. The samples were measured against a negative control subject, reagent control subject and positive control subject. The GMI samples showed no evidence of cytotoxicity, irritation or skin sensitization.

What does all this mean to you?

It means that the materials GMI uses has been proven to be safe. It also means that you can TRUST that GMI is committed to delivering the safest products and services to our customers and your patients. We never know when our family, friends or ourselves will be the patient and that is why we strive to provide the best products. We have taken this step with the intention of affecting change in the marketplace by making this the industry standard.

If you have a probe that needs repair, please use our interactive Probe Assessment Tool to help determine the repairs needed. Probe evaluations and loaners are free to GMI customers.