Sandra Brook, RN, MBA

principal human factors consultant

Sandra Brook is an accomplished human factors regulatory specialist with a strong commitment to bringing medical advancements to market. Sandra’s expertise includes strategizing and executing usability and human factors activities that help create designs that are innovative and safe and enhance the probability of achieving successful regulatory submissions. She produces use related risk analyses (URRAs) that inform summative usability validation studies to prove devices can be used safely and effectively. While collaborating with regulatory and quality teams, she ensures medical device designs are optimized to mitigate use-related risk to an acceptable level to meet industry expectations and standards.

Sandra’s professional journey started as a nurse, caring for patients in San Diego’s emergency departments. This allowed her to intimately understand patient needs, and the critical role medical technology plays at the bedside. She now applies her clinical acumen and human factors expertise to elevate patient safety by reducing medical errors, and ultimately leading to a safer and healthcare bedside.

For more information, please see her LinkedIn profile.