A medical device or material that comes in contact with a patient's body is expected to perform without the occurrence of any harm to the patient.
The U.S. Food and Drug Administration (FDA) and Medical Device Regulation (MDR) are urging greater regulatory requirements for medical devices, which is also reflected in the assessment of biocompatibility.
Watch our on-demand webinar to learn more about:
- Overall biological evaluation strategy
- Challenges in evaluation of biocompatibility
- Key factors affecting biocompatibility
- Fundamentals of biological evolution plan
Sairam Arava, UL staff engineer
Sairam Arava is a Toxicology & GLP Subject Matter Expert for Medical devices testing division in UL India. He is an expert in medical devices biocompatibility toxicological testing and GLP.
April 14, 2021