NABL AccreditedCDSCO MD-40ISO 10993

Medical Device Testing & MDR 2017

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.

Get a Quote Call +91-7428116100

Accreditations & Approvals

NABL accreditation
NABLISO/IEC 17025:2017
CDSCO accreditation
CDSCODrug regulator
FSSAI accreditation
FSSAIFood regulator
WHO Prequalified accreditation
WHO PrequalifiedBangalore lab
BIS accreditation
BISIS standards
USFDA accreditation
USFDAInspected
AYUSH accreditation
AYUSHMinistry registered
APEDA accreditation
APEDAExport approval
ISO accreditation
ISO9001 / 22000
EIC accreditation
EICExport Inspection
NABL accreditation
NABLISO/IEC 17025:2017
CDSCO accreditation
CDSCODrug regulator
FSSAI accreditation
FSSAIFood regulator
WHO Prequalified accreditation
WHO PrequalifiedBangalore lab
BIS accreditation
BISIS standards
USFDA accreditation
USFDAInspected
AYUSH accreditation
AYUSHMinistry registered
APEDA accreditation
APEDAExport approval
ISO accreditation
ISO9001 / 22000
EIC accreditation
EICExport Inspection

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 (ISO 10993-5), Sensitisation and Irritation (ISO 10993-10), Systemic Toxicity (ISO 10993-11), Genotoxicity (ISO 10993-3), Implantation (ISO 10993-6), and Haemocompatibility (ISO 10993-4) per the ISO 10993 series.

Learn more

Bioburden Testing

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

Learn more

ETO Residual Testing

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

Learn more

Extractables & Leachables

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

Learn more

Packaging Validation

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

Learn more

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.

Learn more

Particulate Matter Testing

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

Learn more

Sterility Testing

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

Learn more

Material Characterisation

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

Learn more

Medical Device Testing Lab Locations

Three Auriga labs carry medical device testing scope. CDSCO MD-40 registration is held at Delhi HQ and Bahadurgarh; biocompatibility scope is held at Delhi and Bangalore.

Primary MD Lab

Delhi HQ

NABL TC-7375 CDSCO MD-40

Arbro Analytical Division. Full medical device scope — biocompatibility (ISO 10993), bioburden, ETO residuals, E&L, packaging validation, blood bag, particulate matter, and material characterisation.

View Lab →

CDSCO MD-40 Lab

Bahadurgarh (Alcatec)

NABL TC-7710 CDSCO MD-40

Alcatec Research Laboratories, a fully owned subsidiary of Auriga Research. CDSCO MD-40 registered for medical device testing under MDR 2017.

View Lab →

Biocompatibility Lab

Bangalore

NABL TC-5496 ISO 10993

ISO 10993 biocompatibility scope for cytotoxicity, sensitisation, irritation, and supporting endpoints. Serves South India device manufacturers with regional sample handoff.

View Lab →

Why Auriga for Medical Device Testing

CDSCO MD-40 at Two Labs

Delhi HQ and Bahadurgarh (Alcatec) both hold CDSCO MD-40 registration under the Medical Device Rules 2017 — the mandatory credential for CDSCO-accepted device reports across Class A through Class D.

Full ISO 10993 Series

Complete biocompatibility battery in scope: cytotoxicity (-5), genotoxicity (-3), haemocompatibility (-4), implantation (-6), sensitisation and irritation (-10), systemic toxicity (-11), and chemical characterisation (-18).

NABL ISO/IEC 17025:2017 + ILAC MRA

NABL accreditation under ISO/IEC 17025:2017 with international recognition through the ILAC mutual recognition arrangement &mdash; reports accepted by CDSCO, EU Notified Bodies, FDA (supporting data), ASEAN, GCC, and African regulators.

Three Lab Locations

Delhi HQ (primary MD scope), Bahadurgarh / Alcatec (CDSCO MD-40), and Bangalore (biocompatibility) &mdash; parallel capacity, regional sample handoff, and complementary scopes under one group.

Regulatory Pathway Guidance

Test selection guided by device classification, body-contact type, contact duration, and target market &mdash; Biological Evaluation Plan (BEP) framework per ISO 10993-1 with the right tests scoped at proposal stage.

Multi-Market Dossier Coverage

CDSCO Form MD-9 and MD-15 registrations, FDA 510(k) and PMA supporting data, EU MDR technical files reviewed by Notified Bodies (BSI, TÜV SÜD, DEKRA), and Gulf SFDA / ASEAN / Africa submissions &mdash; one report package, multiple jurisdictions.

Who Needs Medical Device Testing

Six buyer profiles that route medical device compliance testing to Auriga.

  • Device manufacturers filing CDSCO Class B, C, or D registrations under MDR 2017 needing the full biocompatibility, sterility, packaging, and device-specific test package.
  • FDA 510(k) and PMA submitters needing NABL-accredited test data as supporting evidence in US regulatory dossiers.
  • EU MDR technical file preparers requiring ISO 10993 biocompatibility and ISO 11607 packaging validation reports accepted by Notified Bodies (BSI, TÜV SÜD, DEKRA, DNV).
  • Implant manufacturers (orthopaedic, cardiovascular, ophthalmic, dental) requiring chronic implantation, haemocompatibility, and full E&L characterisation for high-risk device approval.
  • Combination product developers (drug-device, biologics-device) requiring extractables and leachables, drug-material interaction studies, and integrated CDSCO submission packages.
  • Single-use device manufacturers (syringes, catheters, IV sets, wound dressings) needing bioburden, ETO residuals, and packaging integrity for batch release.
  • Blood bag and transfusion set manufacturers needing IS 7000 / IS 12018 / ISO 3826 testing for CDSCO registration and BIS ISI certification.
  • CDSCO regulatory consultants assembling device master files on behalf of manufacturer clients across Class A through D.

How It Works

Four steps from quote to NABL-accredited and CDSCO-accepted report.

1

Get a Quote

Share your device type, classification (Class A / B / C / D), body-contact type, contact duration, sterilisation method, and target market (CDSCO / FDA / CE / Gulf SFDA). Your dedicated SPOC confirms the Biological Evaluation Plan (BEP), test scope, applicable ISO and IS standards, and sample-item portion (SIP) required for your device before you dispatch.

2

Send Your Sample

Dispatch sterile-handled device samples with a completed Test Request Form to the appropriate Auriga lab (Delhi HQ, Bahadurgarh / Alcatec, or Bangalore for biocompatibility). Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt.

3

Testing and QA Review

Your sample is tested per the agreed ISO and IS protocols by Auriga's microbiology, chemistry, and biocompatibility teams in clean-room or controlled-environment facilities. Every result passes through formal internal QA review and sign-off before the report is generated.

4

Receive Your NABL Report

Your NABL-accredited test report is delivered digitally within the committed turnaround time. Reports carry NABL ISO/IEC 17025:2017 accreditation and CDSCO MD-40 lab registration where applicable; accepted by CDSCO Form MD-9/MD-15, FDA 510(k), EU Notified Bodies, and contract sterilisers for ISO 11135 / 11137 dose audits. Track sample status in real time through YLIMS.

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 MD-40 registered medical device testing at Delhi HQ and Bahadurgarh (Alcatec), with ISO 10993 biocompatibility scope at Bangalore. Full series — biocompatibility, bioburden, ETO, E&L, packaging validation, sterility, blood bag, particulate matter, and material characterisation.

+91-7428116100 Get a Quote

Frequently Asked Questions

What testing does each device class require under MDR 2017?
Under the Medical Device Rules 2017, devices are classified A (lowest risk) to D (highest risk). Class A non-sterile, non-measuring devices are largely exempt from CDSCO licensing — basic conformity testing only. Class A sterile / measuring and Class B devices require State Licensing Authority approval and a notified-body audit, with bioburden, ETO residuals, packaging integrity, and basic biocompatibility testing. Class C devices require CDSCO Central Licensing Authority approval and the full ISO 10993 biocompatibility battery, sterility assurance, extractables and leachables, and device-specific performance testing. Class D devices (highest risk — implants, life-support, drug-device combinations) require the most extensive dossier including chronic implantation studies, full E&L characterisation, and biological evaluation per the BEP framework.
Is Auriga a CDSCO MD-40 registered medical device testing laboratory?
Yes. Both the Delhi HQ (Arbro Analytical Division) and Bahadurgarh (Alcatec Research Laboratories) hold CDSCO MD-40 registration as medical device testing laboratories under the Medical Device Rules 2017. Reports issued from MD-40 registered labs are accepted by CDSCO for device registration submissions across all device classes.
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.

Related Pages

Biocompatibility Testing (ISO 10993) | Packaging Validation (ISO 11607) | Extractables & Leachables (ISO 10993-18) | Bioburden Testing | ETO Residual Testing | Blood Bag Testing | Sterility Testing (ISO 11737-2) | Particulate Matter Testing | Material Characterisation | CDSCO Approved Lab | NABL Accredited Lab | Pharmaceutical Testing

Type to search services, tests, and locations…