Situation:
Company develops and produces high-quality dental devices and is a leader teeth whitening technologies
Solutions:
- Our experts analyzed the product, reviewed ISO 10993-1 and FDA G#95 memorandum.
- Devised testing strategy for class I device contacting the skin and mucosal membrane area for less than 24 hrs.
- Identified the necessary tests required to complete the biocompatibility testing
- Identified and analyzed different components of the device. Samples required to conduct the tests were accurately identified
- Conducted the tests in GLP environment for Biocompatibility ISO 10993-1
- Analyzed results and compiled the test data
- Prepared a detailed test report binder ready to submit to FDA 510 K approval
Value:
Devised a testing strategy and designed the tests required. Conducted all the tests and overcome couple challenges without much interaction from client during testing. Produced a Biocompatibility ISO 10993-1 binder for the device ready to submit to FDA. This activity resulted our client in a saving of ~30% of the original cost quoted by the leading test labs and 4 weeks of time. The client was really excited with the outcome.