Biocompatibility Testing for an Orthopedics Device Manufacturer Catering to Joints Replacements

Biocompatibility testing for an Orthopedics device manufacturer catering to joints replacements

Situation: Company is well established designer and manufacturer of joint replacement implants and in existence for over 30 years. Additionally, company also designs and manufactures the surgical instruments utilized by physicians for joint replacements and surgical procedures.

Solutions:    

Our experts analyzed the product, reviewed ISO 10993-1 and FDA G#95 requirements Devised testing strategy for class I device contacting the skin, blood, and bone area for less than 24 hrs.

Identified the necessary tests required to complete the biocompatibility testing Identified and analyzed different components of the device.

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Samples required to conduct the tests were accurately identified Conducted the tests in GLP environment for Biocompatibility as per 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 without a glitch in GLP environment. Produced a Biocompatibility ISO 10993-1 binder for the device ready to submit to FDA. This activity resulted in a saving of ~30% of the original cost quoted by the leading test labs and 4 weeks of time to our client.