Biocompatibility is a crucial aspect of medical device design and manufacturing, ensuring that devices do not cause adverse reactions when used in clinical settings. This comprehensive course evaluates the final finished device, including all materials and manufacturing processes used to create it, to ensure its safety for patient use.
The evaluation process is conducted through a risk management framework, combining both testing and risk assessments (paper evaluations). This approach helps to mitigate any potential adverse reactions when the device is used as intended. By understanding and applying these principles, professionals can ensure that their devices meet the highest standards of safety and efficacy.
Built on content presented by Nelson Labs since 2018, this course offers a deep dive into the biocompatibility evaluation process. Participants will gain a thorough understanding of the risk-based approach to biocompatibility, which is essential for both FDA and EU MDR compliance.
Key learning objectives include:
- Understanding the risk-based approach to biocompatibility evaluations: Learn how to systematically evaluate the risks associated with medical devices and how to use a combination of testing and risk assessments to ensure device safety.
- Considerations for FDA and EU MDR: Gain insights into the regulatory requirements for biocompatibility in both the United States and the European Union, and learn how to navigate these complex frameworks effectively.
- Discussion on testing considerations: Explore the various testing methods used in biocompatibility evaluations, including in vitro and in vivo tests, and understand how to interpret and apply the results to your device development process.
Upon completion of this course, participants will be equipped with the knowledge and skills needed to conduct comprehensive biocompatibility evaluations, ensuring that their medical devices are safe and effective for clinical use.