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Medical Device Testing | KM Bioserasi
Trusted Medical Device Testing

Medical Device

Ensuring safety, compliance, and performance our comprehensive medical device testing, including biocompatibility and regulatory evaluations, delivers trusted results at competitive prices.

Our Testing Services

Cytotoxicity Test

ISO 10993-5

Evaluating the toxicity of medical devices and materials on living cells.

Genotoxicity Test

ISO 10993-3

Determining the potential of a device to induce genetic damage.

Irritation Test

ISO 10993-23

Assessing the localized inflammatory response to device materials.

Sensitization Test

ISO 10993-10

Estimating the potential for contact sensitization by medical devices.

Systemic Toxicity

ISO 10993-11

Evaluating the potential for generalized adverse effects on the body.

Pyrogen Test

USP

Detecting the presence of pyrogens that cause fever in patients.

Implantation Test

ISO 10993-6

Assessing local effects after implantation in living tissue.

Haemocompatibility

ISO 10993-4

Evaluating the effects of medical devices in contact with blood.

Test Methods & Guidelines

Our laboratory rigorously adheres to internationally recognized testing methods to guarantee precision and reliability.

  • ISO 10993 Series
  • US Pharmacopeia (USP)

Regulatory Compliance

We support your submission process by testing against the requirements of major global regulatory bodies.

MDA

Medical Device Authority

USFDA

U.S. Food & Drug Admin

EU MDR

Medical Device Regulation

Ready to Ensure Your Device's Compliance?

Get trusted testing results at competitive prices. Contact our team today to discuss your testing requirements and request a customized quotation.

kmbioserasi@ukm.edu.my

We aim to respond to all inquiries within 24 hours.