Medical Devices

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

We offer a wide range service of testing services as follows:

  • Cytotoxicity Test ISO 10993-5
  • Genotoxicity Test ISO 10993-3
  • Irritation Test ISO 10993-23
  • Sensitization Test ISO 10993-10
  • Systemic Toxicity Test ISO 10993-11
  • Pyrogen Test USP
  • Implantation Test ISO 10993-6
  • Haemocompatibility Test ISO 10993-4

Test Method and Guidelines:

  • ISO 10993
  • US Pharmacopeia

Regulatory Compliance

  • Medical Device Authority
  • USFDA
  • EU Medical Device Regulation

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👉 Email us at kmbioserasi@ukm.edu.my and request a quote today!