Built to Withstand 5 Validation Checks
Our method validation is part of our medical device testing services — custom analytical methods proven fit-for-purpose on certified instrumentation at our Oragadam laboratory.
Call 90876 86986 WhatsApp UsA test result is only as good as the method behind it.
Our method validation is one of the eight capabilities in our medical device testing services, confirming that a custom analytical method is genuinely fit for purpose before it’s used to release your material or device. Every validation run at our Oragadam lab is aligned to ICH Q2(R1) guidelines, giving you documented proof that the method itself can be trusted — not just the result it produces.
What Our Method Validation Covers
Five parameters, checked before a method is put into use
Accuracy & Precision
Confirming a method returns correct, repeatable results.
Specificity
Verifying a method measures your target and nothing else.
Linearity & Range
Establishing where a method holds up across a concentration range.
Robustness
Testing how small, deliberate variations affect the method’s output.
Every Reading, Cross-Checked
This validation process isn’t a one-pass exercise — each parameter is checked, repeated, and cross-verified by an analyst before a method is signed off as fit for routine use.
- ✓ Repeated measurement for confirmed precision
- ✓ Unique validation reference ID at intake
- ✓ Analyst sign-off logged at every stage
The Detail That Decides Validity
Validation accuracy lives or dies on detail this fine — calibrated magnification, controlled lighting, and a documented setup that’s reproducible every single time the method is run again.
- ✓ Calibrated instrumentation for every run
- ✓ Documented, reproducible setup conditions
- ✓ Maintenance records kept for every instrument
Consistent, Sample After Sample
To prove a method is repeatable, we run it across multiple samples from the same batch and compare results — the evidence that separates a validated method from a lucky first run.
- ✓ Multi-sample repeatability testing
- ✓ Batch-to-batch consistency comparison
- ✓ Documented statistical evaluation included
How Our Method Validation Works
Four steps, part of our broader medical device testing services
Method Design
Method drafted around your material’s chemistry.
Parameter Testing
Accuracy, specificity, linearity & robustness checked.
Statistical Review
Results evaluated against ICH Q2(R1) criteria.
Certified Report
Delivered digitally, ready for your QA documentation.
Parameters Behind Our Method Validation
| PARAMETER | WHAT IT CONFIRMS | STANDARD |
|---|---|---|
| Accuracy | Closeness to the true value | ICH Q2(R1) |
| Precision | Repeatability across runs | ICH Q2(R1) |
| Specificity | Selectivity for the target analyte | ICH Q2(R1) |
| Linearity & Robustness | Consistency across range & variation | ICH Q2(R1) |
Kiyo R&D Lab – Oragadam
Our method validation and medical device testing services are based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.
Frequently Asked Questions
What does this validation process actually confirm? +
Method validation confirms that a custom analytical method is accurate, precise, specific, linear, and robust before it’s used to test your material or device — part of our broader medical device testing services.
When do I need method validation instead of a standard test? +
If a standard method doesn’t fit your material’s chemistry, or you’re working with a novel formulation, method validation builds and proves a custom method aligned to ICH Q2(R1).
What is the turnaround time for method validation? +
Turnaround depends on how many parameters need to be tested. Contact us with your requirement for an exact timeline.
Can method validation be combined with other services? +
Yes. Method validation is often the first step before running raw material analysis, trace metal analysis, or NMR spectroscopy on a novel material.
How do I get a quote for method validation? +
Call us at 90876 86986, message us on WhatsApp, or fill in the enquiry form below with your material details and required parameters.
Related Medical Device Testing Services
Get Your Analytical Method Validated
Talk to our Oragadam lab team about this validation service as part of your medical device testing services requirement.
Call 90876 86986 WhatsApp UsRequest Method Validation
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