Documenting a human factors engineering plan is critical. Download our guide to jumpstart yours with our proprietary human factors plan table of contents so you don’t miss any of the essential [...]
Follow this one-page infographic guide to lead you to the proper FDA class for your medical device. If you don’t know which class your product falls into, you risk creating a development plan [...]
If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]
To shape a positive medical device user experience, you should focus on product information design throughout your medical device development process. For instance, developers too frequently [...]
To meet the FDA’s standards for medical devices, you must complete user interface specifications or requirements. So how do you properly complete the user needs section of user interface [...]