COURSE B: Regulatory Toxicology of Medical Devices: An Advanced Course
Prerequisite: Biocompatibility of Medical Devices: Two Day Certification Course
This 2-day training course is designed for those who have received certification in the NAMSA Advisory Services Biocompatibility of Medical Devices Two Day Certification Course. The objective of this course is to teach beyond the basics of Tables A and B in ISO 10993. In addition to traditional medical devices, we will address combination products and biologics. Participants will not only learn how to assess their device for biological risks but also understand when testing is necessary. They will discover where to find information and how to incorporate it into their assessments. Calculating safe limits will also be discussed. Hands-on workshops will provide an opportunity to work with case studies on real medical devices which will provide an understanding of how to present data in a submission. Participants will walk away with the knowledge of how to plan and a strategy to endure potential obstacles.
Upcoming Event Dates:
June 5-6, Brussels, Belgium
July 10-11, Philadelphia, PA