Biocompatibility Testing For Global Manufacturer of Medical Mattresses

Biocompatibility Testing For Global Manufacturer of Medical Mattresses

Situation:
The company is ISO 13485 certified designer and manufacturer of medical therapeutic support surfaces
and patient positioning devices, which are primarily used for the prevention and treatment of pressure
wounds experienced by patients with limited to no mobility
Solutions:

 Our experts analyzed the product, reviewed ISO 10993-1 and FDA G#95 requirements
 Devised test plans for device contacting the skin surface 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
 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. 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 4weeks of time. The client was really excited with the outcome.