Biocompatibility Testing

Biocompatibility is used to describe appropriate biological requirements of biomaterials used in a medical device. Biocompatibility has also been described as the ability of a device material to perform with an appropriate host response in a specific application. Biocompatibility assessment is a necessary part of the overall safety evaluation of a medical device.

FDA has developed International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s) for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.

STEMart offers comprehensive biocompatibility testing for both in vitro and in vivo assessments. With extensive expertise in biocompatibility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.

STEMart performs cost-effectiveness full services that deliver reliable results for your medical devices. Our experts can evaluate the medical device to propose an appropriate plan for testing to ensure your medical device meets the required regulatory compliance. If you have any additional questions about Biocompatibility testing, or would like to consult with the experts at STEMart, please feel free to contact us.

References

• Zohuri, G., “Polymer science: a comprehensive reference.” (2012).
• Black, J., Biological performance of materials: fundamentals of biocompatibility. (2005).