The FDA has greatly increased it’s interest in Human Factors and Usability issues as they pertain to medical devices. The recent publication of IEC 62366, “Medical Devices – Application of Usability Engineering to Medical Devices” reinforces this trend. Our expertise in the areas of Usability Engineering and Human Factors design allows us to help you navigate these new compliance waters.

Below are excerpts from various FDA documents regarding Human Factors and Usability:

Human Factors in the QS Regulations

Paragraphs c, f, g of Section 820.30 of Design Controls

"Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to device are appropriate and address the intended use of the device, including the needs of the users and patient."

"…conduct appropriate human factors studies..."

"...human interface includes both hardware and software characteristics..."

“Design validation shall ensure that devices conform to defined user needs, intended uses, and shall include testing or production units under actual or simulated use conditions”

“Device validation shall include…risk analysis…”

Human Factors in CAPA

“Any death, even if the manufacturer attributes it to ‘user error’ will be considered relevant by the FDA and will potentially have a high risk associated with it.”

“User error is still considered to be a nonconformity, because human factors and other similar tools have been considered during the design phase of the design.”

Comments regarding the new standard are summed up in this article IEC 62366.

Please contact us to discuss how our experience can help you meet your clinical and business goals.