At CellBios, quality is not just a standard rather it’s a commitment to process as well as safety of the each and every product.Safety and reliability of medical devices are paramount in the global healthcare and life sciences industries. To comply the regulatory requirements, we implement rigorous quality control. Each and every stage of processes shall under rigorous QC procedures to ensure that every manufactured product of CellBios meets the respective standards (IMDR, ISO, ASTM, CE & FDA).

The in-house QC laboratory is designed to test and validate raw materials process and finished products. The objective of Quality Control is to ensure that, all our products are safe, effective and reliable for healthcare applications which complies as per the Regulatory guidelines.

Key Quality Control Processes are

 Product Design & Engineering

• Development of innovative medical and biotechnological products designed to improve
• patient outcomes and operational efficiency.
• Tailored solutions based on in-depth research, user feedback, and the latest advancements in healthcare technology.
• Robust design and prototyping processes ensuring functionality, safety, and ease of use.

Performance Testing (Non-Clinical)

Testing parameters are:

• Visual Inspection
• Leak test
• Burst Test
• Tensile Test
• Aging Test
• Hanging Test
• Spike Port Test
• Liquid Nitrogen Test
• Long Term Freezing Test
• Thermal Shock Test
• Multiple freeze / thaw cycles
• Transparency Test
• Particle Test

Advanced Biological Evaluations

We prioritize the biological safety of our products through a variety of biocompatibility tests, including:

• Bacterial Endotoxins Test
• Microbial Ingress Study
• Hemolysis test
• Systemic injection
• Intracutaneous injection
• Implantation test
• Kinetic Limulus Amebocyte Lysate (LAL) test
• E&L
• Cytotoxicity
• Genotoxicity
• Hemocompatibility