Essentials of a Medical Device Manufacturing Plan
This manufacturing guide outlines the most important information you need in your manufacturing plan to ensure timely project completion.
The Only Human Factors Planning Guide You Need
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 [...]
Your Guide to FDA Device Classification
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 [...]
Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
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 [...]
Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
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 [...]
How to Complete the User Needs Section of User Interface Requirements
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 [...]
