Design Validation VS. Human Factors Validation
Human factors and risk create a lot of confusion in the medical device industry. What do you need to do from a design control perspective?
Mary Beth Privitera, principal - human factors at HS Design and AAMI Human Engineering Committee co-chair describes the similarities and differences between human factors vs. design validation in a Greenlight Guru Podcast.
Learn more by listening to the Global Medical Device Podcast here: https://soundcloud.com/medical-device-podcast/design-validation-vs-human-factors-validation
Mary Beth Privitera, Principal – human factors at HS Design and AAMI Human Engineering Committee co-chair discusses the similarities and differences between human factors vs. design validation. The in-depth podcast with Greenlight Guru includes: What constitut...
Mary Beth Privitera, Principal – human factors at HS Design and AAMI Human Engineering Committee co-chair discusses the similarities and differences between human factors vs. design validation. The in-depth podcast with Greenlight Guru includes:
- What constitutes human factors validation? It involves an international standard and FDA guidance on rules that medical device professionals need to follow.
- Design validation focuses more on what’s expected during the audit of a human factors file if you have a product that is a high risk for harm or injury.
- Most companies don’t know how to intertwine human factors within design and development practices. Use common sense to make a good product design.
- FDA helps developers understand what they need to do and document early on during the design process to avoid validation issues with a product later on.
- Past sales criteria is a major difference between design and human factors validation because it’s difficult to define and measure ease of use.
- Understand all elements that could impact a product’s design. Study your users and use environment before identifying and fixing design issues.
- A task analysis identifies each step users need to take and serves as evidence that you considered their needs and made necessary compromises.
- Mary Beth busts myths related to human factors and design validation, such as needing three people to evaluate and provide feedback on your product’s design.
Published by HS Design Inc. on Feb 15, 2019
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