Medical Device Testing Services
Built for Precision
Our medical device testing services cover eight analytical capabilities, delivered from our NABL-accredited Oragadam laboratory — built for manufacturers who demand certainty.
Call 90876 86986 WhatsApp UsMedical devices carry zero tolerance for material or chemical failure, which is why our medical device testing services verify every polymer, coating, and raw material before it reaches a patient.
Our medical device testing services give manufacturers, importers, and OEMs the analytical evidence needed for regulatory submissions, batch release, and design-history files. From trace metal screening to structural confirmation by NMR, our medical device testing services are delivered from our Oragadam lab with documented, defensible reports.
Our Medical Device Testing Services
Eight medical device testing services, one Oragadam laboratory
How Our Medical Device Testing Services Work
Four steps from sample to certified report
Sample Submission
Logged at our Oragadam facility with a unique reference ID.
Analytical Testing
Validated methods run across our capabilities.
Report Compilation
Compiled into a documented report with method references.
Certified Delivery
Delivered digitally, ready for your QA documentation.
Methods Behind Our Medical Device Testing Services
| METHOD | IDENTIFIES | STANDARD |
|---|---|---|
| Asbestos Analysis (PLM/PCM) | Asbestos fibres in materials & fillers | ISO 22262 |
| Trace Metal Analysis (ICP) | Elemental impurities & catalyst residues | ICH Q3D |
| Residual Solvent Analysis (GC) | Residual processing solvents | ICH Q3C |
| Microbiology Testing | Bioburden & microbial limits | ISO 11737 |
| NMR Spectroscopy | Structural confirmation & identity | IN-HOUSE |
Kiyo R&D Lab – Oragadam
Our medical device testing services are based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.
Frequently Asked Questions About Our Medical Device Testing Services
What do your medical device testing services cover? +
Our medical device testing services test raw materials, components, and finished medical devices made from polymers, elastomers, and metals — covering identity, purity, elemental impurities, residual solvents, and microbiological quality.
Do you provide analytical method development services? +
Yes. If a standard method doesn’t fit your material or device, our team develops and validates a custom analytical method aligned to ICH Q2(R1) guidelines.
What is the typical turnaround time for a test report? +
Turnaround depends on the test panel selected. Standard analytical tests are typically completed within a few working days; contact us with your sample details for an exact timeline.
Can I submit samples directly to your Oragadam facility? +
Yes, samples can be submitted directly at our Oragadam address, or you can call/WhatsApp us first to confirm sample quantity and packaging requirements.
Do your reports support regulatory submissions? +
Our reports document the method, reference standard, and result for each test, giving you the analytical evidence to support internal QA files and regulatory documentation.
How do I get a quote for medical device testing services? +
Call us at 90876 86986, message us on WhatsApp, or fill in the enquiry form below with your device/material details and required tests.
Get Your Medical Device Tested Right
Talk to our Oragadam lab team about our medical device testing services for your material or device.
Call 90876 86986 WhatsApp UsRequest Our Medical Device Testing Services
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