New Medical Device Design Verification and Validation

Posted by Bob Duffy on September 19, 2018 in Design Projects

510(k), Bench Testing, Design

Challenge

Client needed Bench testing conducted to support 510(k) submission for new device.

Actions

• Defined Bench testing required
• Created Bench testing protocols
• Created Bench testing reports from test results
• Reformatting Bench testing documentation to fit 510(k) requirements

Results

Bench testing successfully completed and accepted in subsequent 510(k) submission.