NABL Accredited · CDSCO Recognised · ISO 10993

Medical Device Testing Laboratory India | NABL & CDSCO Accredited

Auriga Research is a NABL-accredited and CDSCO-recognised medical device testing laboratory serving device manufacturers, importers, and regulatory consultants across India. We provide biocompatibility testing (ISO 10993), bioburden analysis, ETO residual quantification, extractables and leachables studies, packaging validation, and blood bag testing for CDSCO registration, CE marking, and multi-market regulatory submissions.

Bioburden 7-10 days | ETO residuals 5-7 days | Biocompatibility from 2 weeks

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Accreditations & Approvals

NABL

CDSCO

FSSAI

WHO

BIS

USFDA

AYUSH

APEDA

ISO

EIC

NABL

CDSCO

FSSAI

WHO

BIS

USFDA

AYUSH

APEDA

ISO

EIC

The Challenge

Medical device manufacturers face complex regulatory pathways — CDSCO registration under MDR 2017, CE marking for EU markets, and FDA requirements for US entry. Each demands specific testing evidence from accredited laboratories. Incomplete or non-compliant test data results in registration delays that cost months of market access.

Our Solution

Auriga Research delivers the complete testing package for medical device registration — from ISO 10993 biocompatibility to packaging validation. Our NABL-accredited, CDSCO-recognised reports are accepted by Indian and international regulatory authorities, enabling manufacturers to pursue multi-market registrations from a single testing partner.

Medical Device Testing Services

Comprehensive medical device testing covering biocompatibility, sterility assurance, chemical characterisation, and packaging integrity for regulatory registration.

Biocompatibility Testing (ISO 10993)

Cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation, and haemocompatibility per the complete ISO 10993 series.

Bioburden Testing

Pre-sterilisation bioburden enumeration and identification per ISO 11737-1 for sterility assurance and sterilisation validation.

ETO Residual Testing

Ethylene oxide (EO) and ethylene chlorohydrin (ECH) residual quantification per ISO 10993-7 for ETO-sterilised devices.

Extractables & Leachables

Chemical characterisation of extractable and leachable compounds from device materials, packaging, and drug-device combinations per ISO 10993-12/18.

Packaging Validation

Sterile barrier system testing per ISO 11607 — seal strength, dye penetration, burst testing, accelerated ageing, and transport simulation.

Blood Bag Testing

Complete testing of blood bags, transfusion sets, and IV devices per IS 7000, IS 12018, and ISO standards for CDSCO registration and BIS certification.

Particulate Matter Testing

Sub-visible and visible particulate contamination testing per USP <788> and ISO 8536 for injectable devices and fluid pathway products.

Sterility Testing

Membrane filtration and direct inoculation sterility testing per ISO 11737-2 and pharmacopoeial methods for terminally sterilised devices.

Material Characterisation

FTIR, DSC, TGA, and elemental analysis for polymer identification, composition verification, and raw material qualification.

Why Choose Auriga for Medical Device Testing

Dual NABL and CDSCO recognition ensures reports are accepted for Indian MDR 2017 registration and international submissions.

Complete ISO 10993 biocompatibility testing battery — from cytotoxicity screening to chronic implantation studies.

Experienced regulatory science team that guides test selection based on device classification, contact type, and target markets.

Accreditation and Compliance

Auriga Research holds NABL accreditation under ISO/IEC 17025:2017 for medical device testing and is recognised by CDSCO as an approved testing laboratory for medical device registration under the Medical Device Rules, 2017. Our accreditation scope covers biocompatibility (ISO 10993 series), bioburden (ISO 11737), ETO residuals (ISO 10993-7), extractables and leachables, and packaging integrity (ISO 11607).

Test reports are accepted by CDSCO for device registration, BIS for ISI certification, EU Notified Bodies for CE marking technical files, and regulatory authorities across ASEAN, Middle East, and African markets. Our NABL accreditation is recognised under the ILAC mutual recognition arrangement, supporting international acceptance of test data.

Proven Track Record

A surgical device manufacturer required the complete ISO 10993 biocompatibility battery and extractables characterisation for simultaneous CDSCO and CE marking submissions. Auriga Research designed the biological evaluation plan, executed cytotoxicity, sensitisation, irritation, and systemic toxicity studies, and completed extractables profiling by GC-MS/LC-MS — delivering the full test report package within the manufacturer's 12-week regulatory timeline. Both CDSCO and the EU Notified Body accepted the reports without queries.

Get Your Medical Devices Tested

NABL-accredited, CDSCO-recognised medical device testing. ISO 10993 biocompatibility, bioburden, ETO, extractables, and packaging validation.

+91-7428116100 Request a Free Quote

Frequently Asked Questions

What medical device tests are required for CDSCO registration in India?

CDSCO registration requirements depend on device classification (Class A through D) and include biocompatibility testing per ISO 10993, bioburden testing, sterility assurance, packaging validation, and device-specific performance testing. Class C and D devices typically require more extensive testing. Auriga Research provides NABL-accredited testing for all parameters required under the Medical Device Rules, 2017, and our reports are accepted by CDSCO for device registration.

What is ISO 10993 biocompatibility testing?

ISO 10993 is the international standard series for biological evaluation of medical devices. It covers cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation, and haemocompatibility testing depending on device contact type and duration. Auriga Research offers the complete ISO 10993 testing battery, with test selection guided by the biological evaluation plan based on your device classification and intended use.

How long does medical device testing take?

Turnaround varies by test type. Bioburden testing is typically completed in 7-10 working days. ETO residual testing takes 5-7 working days. Biocompatibility studies range from 2-12 weeks depending on the endpoints required. Extractables and leachables studies run 4-8 weeks. Contact us with your specific testing requirements for an accurate timeline and project plan.

Do you test blood bags and transfusion sets?

Yes. We offer complete testing for blood bags, transfusion sets, IV sets, and related disposable medical devices per IS 7000, IS 12018, and relevant ISO standards. Testing includes biocompatibility, extractables, particulate matter, container integrity, and functionality testing. Our reports are accepted by CDSCO and BIS for product registration and ISI certification.

Are your medical device test reports accepted internationally?

Yes. Our NABL accreditation under ISO/IEC 17025:2017 is recognised under the ILAC mutual recognition arrangement. Test reports are accepted by CDSCO (India), FDA (US — as supporting data), EU Notified Bodies for CE marking, and regulatory authorities in ASEAN, Middle East, and African markets. We support manufacturers seeking multi-market registrations.