Webinar

End-to-End Human Factors for Medical Devices and Re-processing Usability Testing


Human Factors Engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and effective in real-world use. Join Regulatory Compliance Associates (RCA) and Nelson Labs for a practical, high-level webinar that explores how Human Factors methods help manufacturers reduce use-related risk, improve usability, and meet regulatory expectations across a wide range of medical technologies. This session will walk through the Human Factors process from early user analysis through iterative evaluation, showing how these activities support better design and clearer instructions throughout the product lifecycle.

Attendees will gain insight into how Human Factors applies across diverse use environments, including central sterile processing departments, operating rooms, and home-use settings. Examples will span reusable medical devices, capital equipment, and related products such as personal protective equipment (PPE), highlighting how real-world user behavior and workflows influence safety and performance.

The webinar will also explain why Human Factors is increasingly recommended for products that are reused, reprocessed, or supported by complex instructions. Participants will learn how and where Human Factors studies are conducted, what meaningful results look like, and how those results can be used to strengthen design decisions, improve Instructions for Use, and support regulatory submissions. Backed by the combined expertise of RCA and Nelson Labs, this webinar will equip attendees with practical insights they can apply to improve product safety, usability, and compliance.

By the end of this webinar, participants will be able to:

  • Outline the key steps of the Human Factors Engineering process
  • Explain the role of the Human Factors Engineering process in reducing use-related risks
  • Describe why Human Factors studies are recommended for reprocessing of medical devices and how they are conducted.
  • Apply Human Factors practices to improve design, labeling, and regulatory support

Register to Watch the Webinar

    Presenters

    Jessica Schafersman

    Subject Matter Expert, Design Controls

    Jessica Schafersman is a Biomedical Engineer, Project Management Professional, and Certified Usability Analyst, with more than 20 years of experience in medical product development, combination products, sterile implants, sterile disposables, capital equipment and instrumentation spanning Class I, II, and III... Read More

    Chrystel Lloyd

    Sr. Manager Lab Operations & Strategic Development

    Chrystel Lloyd is the Senior Laboratory Operations and Strategic Planning Manager for the Healthcare Reprocessing section at Nelson Labs. She helps bring new reprocessing offers to Nelson Labs through careful consideration of customer needs and regulatory expectations. She also helps to educate medical device manufacturers on the requirements of validating their reprocessing instructions for use. Chrystel graduated from Arizona State University with a master’s degree in clinical research management with an emphasis on regulatory. She supports the company’s growth and development of healthcare reprocessing globally.