Verification and Validation (V&V) testing is a critical milestone in medical device development. It’s where teams generate objective evidence that a device meets design requirements and performs as intended.
Yet many V&V programs run into delays, failed tests, or repeated studies.
In most cases, the issue isn’t the testing itself, it’s how the program was planned. After supporting V&V programs across catheters, implants, and single-use devices, we consistently see a few common gaps. The good news: they are preventable.
Poorly Defined Design Inputs
V&V testing is only as strong as the design inputs behind it.
If requirements are vague or incomplete, test methods become unclear and pass/fail criteria become subjective. This often leads to rework late in development.
How to avoid it
Define clear, measurable design inputs early. Strong inputs create efficient, defensible verification programs.
Incomplete Worst-Case Analysis
Verification testing must demonstrate performance under worst-case conditions.
For catheter-based devices, this may include tortuous path simulation, bond strength, and fatigue testing. If these conditions are not properly captured, it can lead to additional testing requests during regulatory review.
How to avoid it
Identify worst-case scenarios during protocol development, not after testing begins.
Unrealistic Test Fixtures
Custom test fixtures are often required to simulate real-world use. If fixtures are not designed properly, they can introduce variability or produce misleading data.
Common issues include:
- Artificial loading conditions in fatigue testing
- Improper gripping in tensile testing
- Inaccurate distribution simulation for packaging
How to avoid it
Design fixtures that reflect actual use conditions. Small design details can significantly impact data quality.
Late-Stage Packaging Validation
Packaging validation is frequently underestimated and delayed.
However, standards like ISO 11607 require validation of sterile barrier integrity across sterilization, distribution, and shelf life. This includes seal strength, package integrity, and aging studies.
How to avoid it
Plan packaging validation early and finalize configurations before major testing begins.
Sterilization Validation Delays
Sterilization validation can extend timelines if not planned carefully.
EO, gamma, and e-beam sterilization each require validation for sterility assurance and material compatibility. Developing a new cycle can take months.
How to avoid it
Whenever possible, adopt an existing validated sterilization cycle to reduce risk and timeline.
Streamlining V&V Testing for Medical Devices
Successful V&V programs are built on strong upfront planning.
Clear design inputs, defined worst-case conditions, realistic test setups, and early alignment on packaging and sterilization all contribute to efficient verification and validation.
At Medical Murray, we support V&V testing for medical devices through ISO/IEC 17025 accredited labs, custom fixture development, and protocol design. Our team works across catheters, implants, and single-use devices to help programs move efficiently toward regulatory submission.
For a breakdown of the specific testing required to close out a V&V program, read our guide to closing out V&V programs with confidence.