Raw Material Analysis
for Medical Devices
Part of our medical device testing services — incoming raw material identification and compliance verification, run out of our Oragadam laboratory before your material ever reaches production.
Call 90876 86986 WhatsApp UsEvery medical device starts with a raw material — and every raw material has to prove it is what the label says it is.
Raw material analysis is the first checkpoint in our medical device testing services — confirming the identity, purity, and specification-compliance of polymers, elastomers, metals, and excipients before they enter your manufacturing process. Getting this step wrong means every downstream test, and every finished device, inherits the risk.
What Our Raw Material Analysis Covers
Four checkpoints, run before your material enters production
Identity Confirmation
FTIR/NMR-based confirmation that the material matches its specification sheet.
Purity & Impurity Screening
Elemental and chemical impurity checks against pharmacopeial limits.
Specification Compliance
Verification against ISO and pharmacopeial raw material specifications.
Batch-to-Batch Consistency
Comparative analysis to flag drift between incoming material lots.
Sample Preparation & Chain of Custody
Every raw material sample submitted for our medical device testing services is logged, weighed, and prepared under documented protocol before it reaches any instrument — so the result you receive is traceable back to the exact lot you sent us.
- ✓✓ Unique sample reference ID at intake
- ✓ Documented weighing & sub-sampling protocol
- ✓ Analyst sign-off logged at every stage
Microscopic & Physical Verification
Alongside chemical analysis, our raw material analysis includes microscopic examination to catch what instruments alone can miss — particulate contamination, foreign fibres, and physical inconsistency between lots.
- ✓ Particulate & foreign matter screening
- ✓ Morphological comparison against reference material
- ✓ Documented photomicrographs included in report
How Our Raw Material Analysis Works
Four steps, part of our broader medical device testing services
Sample Intake
Logged at our Oragadam facility with a unique reference ID.
Identity & Purity Testing
FTIR/NMR identification with impurity screening.
Microscopic Verification
Physical & particulate examination under microscopy.
Certified Report
Delivered digitally, ready for your QA documentation.
Methods Behind Our Raw Material Analysis
| CHECK | METHOD | STANDARD |
|---|---|---|
| Identity Confirmation | FTIR / NMR Spectroscopy | IN-HOUSE / PHARMACOPEIAL |
| Elemental Impurities | ICP-Based Screening | ICH Q3D, USP <232>/<233> |
| Residual Solvents | Gas Chromatography | ICH Q3C, USP <467> |
| Physical & Particulate Check | Optical Microscopy | IN-HOUSE |
| Specification Compliance | Comparative Testing vs. Spec | ISO / PHARMACOPEIAL |
Kiyo R&D Lab – Oragadam
Our raw material analysis and medical device testing services are based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.
Frequently Asked Questions
What materials can you test in a raw material analysis? +
We analyze polymers, elastomers, metals, and excipients used in medical devices — checking identity, purity, and compliance before they enter manufacturing, as part of our broader medical device testing services.
How much sample do you need for raw material analysis? +
Sample quantity depends on the tests required. Call or WhatsApp us with your material type and we’ll confirm the exact quantity before you ship or drop off the sample.
What is the turnaround time for raw material analysis? +
Standard identity and purity testing is typically completed within a few working days. Contact us with your material details for an exact timeline.
Can raw material analysis be combined with other medical device testing services? +
Yes. Raw material analysis is often paired with trace metal analysis, residual solvent analysis, and NMR spectroscopy for a complete incoming-material profile.
How do I get a quote for raw material analysis? +
Call us at 90876 86986, message us on WhatsApp, or fill in the enquiry form below with your material details and required tests.
Get Your Raw Materials Verified
Talk to our Oragadam lab team about raw material analysis as part of your medical device testing services requirement.
Call 90876 86986 WhatsApp UsRequest Raw Material Analysis
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