Medical Device IEC 60601-1 Compliance Testing
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.