ISO 10993 · CDSCO · NABL Accredited Full Testing Scope & FAQs →

Medical Device Testing Services

NABL-accredited sterility and safety testing for medical devices — sterility, bioburden (USP <1111>), bacterial endotoxin (LAL), and ethylene oxide residuals (ISO 10993-7). Reports accepted by CDSCO, CE marking bodies, and US FDA.

4 testing services NABL ISO 17025:2017 ISO 10993 Compliant CDSCO Accepted

All Medical Device Testing Services

4 services · ISO 10993 · CDSCO & CE mark accepted

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Medical device sterility
Medical Device Testing

Sterility Testing

₹3,500
Medical device Bioburden
Medical Device Testing

Bioburden Testing Usp

₹4,000
Medical device BET
Medical Device Testing

Bacterial Endotoxin Testing

₹4,000
Medical device Ethylene Oxide Testing
Medical Device Testing

Ethylene Oxide Testing Iso 10993

₹10,000

Regulatory Requirements for Medical Devices

CDSCO mandates documented safety testing under MDR 2017 before market authorisation. Our NABL-accredited reports are accepted by Indian and international regulatory bodies.

CDSCO & MDR 2017

Sterility and bioburden testing required for Class B, C, and D medical devices under Medical Devices Rules 2017 before CDSCO registration.

ISO 10993 Series

Ethylene oxide residual testing per ISO 10993-7; biocompatibility evaluation framework for devices intended for patient contact.

Fast Turnaround

Sterility and BET results in 7–14 days. Priority TAT available for CDSCO submission deadlines and export clearance.

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

Need Medical Device Testing?

NABL-accredited reports for CDSCO registration, CE marking, and export clearance.

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