How to design & conduct usability studies?
This theme includes preclinical testing, clinical trials, usability studies, and other forms of evaluation to gather data on the device's performance, potential risks, and benefits.
Resources
Tips & best
practices
Get user feedback regularly
Conduct regular user feedback sessions and usability tests during the development cycle
Use agile methodologies
Implement agile methodologies in the development process to allow for an iterative approach
Assess risks
Engage cross-functional teams in risk assessment workshops to capture diverse perspectives
Start the regulatory process promptly
Consider filing for FDA, CE Marking and UKCA approval in parallel due to process overlap
