Situation:
The company is the designer and manufacturer of medical therapeutic devices for the health care, consumer and industrial markets. Company is in existence for over 50 years manufacturing devices for dialysis, drug delivery, catheters, etc.
Solutions:
- Our experts analyzed the product, reviewed ISO 10993-1 and FDA G#95 memorandum requirements.
- Devised testing strategy for class I device contacting the skin and tissue area for less than 24 hrs.
- Identified the necessary steps/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 for submission 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.