This webinar is specifically directed to cardiovascular medical device manufacturers that will be conducting particulate matter testing on their product. It’s also applicable to anyone that has questions regarding what steps are necessary to develop a testing scheme, what products should be tested for particulate matter and common pitfalls that manufacturers may encounter when submitting data to regulatory for approval.
The presentation also covers basics of why it’s important to test for particulate matter and why manufacturers and the FDA are concerned about it. Specifics such as test models, in vitro testing and procedure validation are also discussed. Relevant resources such as applicable standards and guidance are introduced as well.
What you may learn from this webinar:
• Specifically what products should be tested for particulate matter
• Critical steps that should be included in a test protocol
• Applicable standards and guidance relating to particulate matter testing of cardiovascular medical devices
• Step by step instructions on developing a particulate matter testing scheme
• Basics of method validation when an in vitro model is used in particulate testing
