Evaluation

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.

Tips & best

practices

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Get user feedback ​regularly

Conduct regular user ​feedback sessions and ​usability tests during the ​development cycle

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Use agile ​methodologies

Implement agile ​methodologies in the ​development process to ​allow for an iterative ​approach

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Assess risks

Engage cross-​functional teams in risk ​assessment workshops ​to capture diverse ​perspectives

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Start the ​regulatory ​process promptly

Consider filing for FDA, ​CE Marking and UKCA ​approval in parallel due to ​process overlap