From Test Plan to Approved Report.
Unmanaged testing is your biggest schedule risk.
Missed standards, last-minute lab bookings, and non-compliant test reports are the leading causes of regulatory delays. Without a dedicated testing manager, each gap can cost months of resubmission time — and by the time a notified body or authority flags a deficient report, your review clock has already reset.
End-to-end testing orchestration, from first standard to final report.
We manage every stage of the testing lifecycle so your submissions are built on solid, defensible evidence.
Test Planning
We map your device's intended use, classification, and target markets to the exact IEC and ISO standards required — eliminating guesswork and gaps before a single test begins.
Lab Selection & Coordination
We identify the right accredited laboratories, negotiate scope and timelines, and act as your technical interface throughout sample preparation and test execution.
Report Review & Submission
We audit every test report for regulatory acceptability — checking standard editions, deviations, and conclusions — so your submission package withstands notified body or authority scrutiny.
Your Complete Testing Package
Structured evidence ready for regulatory submission. Every deliverable is reviewed for compliance before handover.
- Master Test Plan aligned to target market standards
- Lab selection rationale and engagement documentation
- Reviewed and annotated test reports
- Test Summary Report (TSR) for submission
- Gap and remediation log for non-conforming results
A non-compliant test report caught internally takes days to fix. The same issue flagged by a notified body costs you months.
By placing your entire test program under one accountable team with direct regulatory experience, you protect your submission timeline and enter the market with evidence built to withstand scrutiny.
Speak with a Testing Management Specialist TodayFrequently Asked Questions
Common questions about medical device testing management.