Medical Device IEC 60601-1 Compliance Testing

Posted by Bob Duffy on October 3, 2018 in Design Projects, Projects

510(k), Compliance Testing, IEC 60601-1, Standards

Challenge

Client needed appropriate Standards compliance testing defined and conducted in preparation for 510(k) submission.

Actions

• Defined applicable Standards.
• Worked with in-house and external testing resources to define Standards testing plans.
• Worked with in-house and external testing resources to conduct testing per plan.

Results

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