Cart

Your cart is empty
On-Demand Webinar

Avoiding 510(k) Submission Gaps: Practical Human Factors Engineering Strategies to Reduce Rework, FDA Questions, and Project Delays

Early human factors engineering (HFE) decisions directly influence the strength, defensibility, and efficiency of Food and Drug Administration (FDA) 510(k) submissions. Yet, common gaps such as incomplete use-related risk analyses, overlooked users or environments, and insufficient formative evidence often surface during FDA review as additional information requests, validation challenges, or late-stage redesign.
Even submissions that appear complete can encounter unexpected questions that delay clearance, disrupt development times, and increase costs. 
In this session, an ECRI HFE expert will share practical strategies to identify and address usability gaps earlier in development, helping manufacturers strengthen submissions, reduce regulatory friction, and keep projects moving forward.

What You’ll Learn

Gain practical, cross-functional strategies to streamline your 510(k) submission process, including how to:

  • Prevent gaps that trigger FDA follow-up by addressing incomplete use specifications, unidentified hazards, and overlooked user groups
  • Strengthen submissions and reduce delays to accelerate clearance and keep development on track
  • Design for real-world use by accounting for environmental conditions, user workflows, and operational constraints
  • Reduce late-stage rework and inconclusive testing by identifying overlooked usability risks before summative validation testing
  • Apply consistent HFE throughout development to shorten review cycles, support substantial equivalence, and minimize project disruption

Register to view the recording

Bonus Resource:

All registrants will receive a complimentary FDA-aligned human factors resource to help identify usability gaps, mitigate risk, and avoid delays.

Who Should Attend

This session is designed for professionals who are responsible for ensuring safe, usable, and compliant medical devices, including:

  • Design & Development Engineers/Product Design Teams—translating real-world use into safer, more effective designs
  • Product & Program Leaders—protecting timelines, reducing risk, and minimizing late-stage disruption
  • Quality & Risk Management Professionals—mitigating hazards, deficiencies, and late-stage issues
  • Regulatory Affairs Leaders—managing submissions risks and navigating FDA expectations

Speaker

Haroula Tzamaras, PhD

Human Factors Engineer, ECRI

Dr. Tzamaras is a human factors engineer specializing in medical device usability, formative and validation studies, use‑related risk and root cause analysis, and simulation‑based healthcare training. She partners with medical device manufacturers to identify and mitigate usability risks, supporting regulatory readiness through evidence‑based HFE insights.

Her work focuses on improving device safety, evaluating device performance, optimizing clinical workflows, and ensuring that technologies support safe, effective, and reliable use in real‑world healthcare settings. She delivers human factors assessments and develops practical, safety‑focused solutions that help healthcare organizations and manufacturers maximize technology performance in clinical environments.

Dr. Tzamaras holds a PhD in industrial engineering with a human factors specialization from Pennsylvania State University. Her research in simulation‑based medical training has led to multiple publications, patents, and national presentations. She also teaches graduate‑level human factors analysis methods at Tufts University and is an active leader in the human factors community.