About Biocompatibility Testing for Medical Devices
Biocompatibility testing is in the spotlight with regulatory bodies – especially with the recent release of the updated European MDRs and the FDA’s Guidance document on ISO 10993-1.
It is essential for medical device manufacturers to have an understanding of the current landscape for biocompatibility testing while keeping an eye on the future trends that will affect future requirements.
This seminar will discuss the recent changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices.
Attendees will understand and apply ISO 10993-1 and the FDA Guidance on its use. They will know how to use the ISO documents to locate information that you need.
Understand what tests to select and how to choose among various options.
By attending this seminar, attendees will get answers of these questions:
When is testing not the only option?
Understand how to apply Materials characterization, and more importantly, learn how to use the information to understand biological safety?
Understand ISO 14971 and how to use it?
Learn how to use ISO 10993-1 as a tool for hazard identification?
Learn how to develop a program that guides your device on the regulatory path and reduces your time to market?
Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan.?