Evidence-Based Approaches for the Biological Safety Assessment of Medical Devices
Last Updated: May 05, 2023
Overview
The biological safety assessment evaluates the potential of medical devices to produce adverse health effects. This process largely relies on the use of animal-based, legacy test methods that have remained unchanged for many decades. However, some have questioned the clinical relevance of these animal-based test methods. Moreover, these expensive and time-consuming test methods can increase the time needed for regulatory approval and restrict innovation in device and test method development.
In this webinar brought to you by Sartorius, Ron Brown will outline the need for a new and more agile approach for the biological safety assessment of medical devices.
- Document type: Webinar
- Watch time: 65 minutes
- Speaker: Ron Brown, Director Risk Science Consortium
Key Takeaways
- The problems associated with current approaches used to assess the biological safety of medical devices
- The development of an evidence-based toxicology (EBT) approach for assessing the validity of new and existing testing strategies
- How to incorporate data-driven methods into a streamlined workflow for medical device safety assessment
- The implications of this proposed approach for patients, test method developers, medical device manufacturers, and regulatory agencies
This Resource is Designed for:
- Lab Researchers and Managers
- Lab Technicians
- Medical Devices Manufacturers
- Scientists
- Engineers
- Lab Post Doc
Applications Supported:
- Life Science Research
- Applied Industries
- Quality Control & Testing