Medical Devices

With the rapidly prevalent spread of Covid 19, medical devices industries around the globe have been increasing production at a similar speed in order to deliver us the protection we need. At Makmal Bioserasi we offer testing in accordance to the ISO 10993 series.

Research and Development
Regulatory (Local) - MDA Submission
Regulatory (International) -EU/FDA 510K
Biocompatibility Testing
Cytotoxicity Test

Qualitative

  1. MEM Elution Assay

Quantitative

  1. MTT Assay
Irritation Test
  1. Animal Irritation Test
  2. Animal Irritation test by Intracutaneous (Intradermal) administration
Skin Sensitization Test
  1. Skin sensitization test, Closed-patch test, Buehler method
  2. Skin Sensitization Assay (Maximization)
Systemic Toxicity Test
  1. Acute Systemic Toxicity Study (Intraperitoneal)
  2. Acute Systemic Toxicity Study (Intravenous)
  3. Acute Oral Toxicity - Acute Toxic Class Method
Genotoxicity Test
  1. Bacterial Reverse Mutation Test
Pyrogenicity Test
  1. Rabbit Pyrogen Test