Situation:
The company is well established medical device company specialized in developing Operating Room (OR) products. Company has over 35 years’ experience and is an ISO certified manufacturer of specialty surgical tables, traction products, positioners, surgical instrument care products, and more. Client wanted to submit for 510 (k) clearances (FDA) and one of the requirements for this submission is to demonstrate biocompatibility of the device.
Solutions:
- Our experts analyzed the product, reviewed ISO 10993-1 and FDA G#95 requirements
- Devised test plans for class I device contacting the normal skin and breached skin area for less than 24 hrs.
- Identified the necessary steps 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 input from client during testing. Developed the biocompatibility binder 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.