Clinical data requirements have strengthen under the MDR, to avoid market disruption and to help ensure legacy and new products reach EU customers, it is critical that manufacturers know the different methods available to collect clinical data and the importance to collect the appropriate data.
What we will cover:
- Identify clinical data currently available for the device and establish data gaps
- Discuss different clinical study designs and common mistakes seen
- Review the requirements and identify the appropriate data to collect
Michelle McDonough, Senior Director, Regulatory & Clinical Affairs, MCRA
- 11+ years of regulatory & clinical affairs experience
- Responsible for drafting, reviewing, and strategizing US and international regulatory submissions
- Additional prior roles include Orthopedic Research Foundation of the Carolinas
- Leading team member, assisting clients in remediating files to meet the new European medical device guidelines.