Event
Regulatory requirements for Active Medical Devices
- 12 Feb 2020
- 12:00PM
- Save to my Calendar
- Webinar, Sydney, NSW, Australia
About the Event
This presentation will explore the compliance and certification requirements for creating and marketing active medical devices. The role of notification bodies such as the TGA, FDA, CE will be outlined along with the main regulatory standards.
The key activity of classifying your device is explained. We then set out the pathway to certification, including the role of predicate devices, verification and validation, clinical trials and the certification process.