Description: Usability studies and human factors engineering studies become more and more important during pre-market submissions (for the US market) and during technical file reviews by European notified bodies.
Regulatory professionals must work with different entities both in the organization and outside of the organization to plan and implement the most beneficial usability study design while considering compliance aspects and regulatory strategy.
Similarities and differences between US and European approaches will be reviewed, including relevant case studies and practical tips for the appropriate design of such studies and combining them as part of the pre-market submission.
Emphasis will be given to global submissions and the implementation of a global regulatory strategy when designing, conducting, and summarizing usability studies.
The session will include IVD and Medical Device perspectives.
Learning Objectives:
Upon completion, participant will be able to describe the relevant EU and USA guidance documents
Upon completion, participant will be able to explain the similarities and differences between EU approach and the US approach regarding Usability and Human Factors Studies
Upon completion, participant will be able to prepare a usability study report and/ or usability study design which is in line with the company's regulatory strategy, based on considerations such as intended markets, planned time to market, participants numbers and qualifications etc...
