Activity Details
Using Standards for Medical Devices and Supplies to Support Good Regulatory Practice
:Objectives
Understand the shared goal of medical device standards and regulation to enhance the safety and effectiveness of devices so that patient outcomes are improved.
Know who creates standards and how standards are developed
Be familiar with the different methods regulators use to apply standards in medical device review.
Be prepared to participate in standards development and draft standards that are regulatory-ready
:Topics
The shared value proposition of medical device standards and regulation—Enhanced device safety, effectiveness, and availability
The global landscape of medical device standards—Who develops them and how.
How manufacturers employ standards in designing, manufacturing and maintaining medical devices
Methods for including standards in the regulatory process of clearing devices for marketing
How to participate effectively in creating consensus medical device standards
How to ensure medical device standards are optimized for regulatory use.
:Audience
GSO Technical Committee for Medical Devices and Supplies (TC11) members.
The primary audience for this workshop is medical device regulators, but health authorities, device manufacturers, and clinicians would also benefit from attending