Insights From Our Team

This manufacturing guide outlines the most important information you need in your manufacturing plan to ensure timely project completion.

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 components.

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 that doesn’t align with FDA requirements and doesn’t properly mitigate risk.

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 resubmit it for another chance at FDA approval. Learn how to make certain it’s the right time for your human factors study.

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 procrastinate their Information for Use (IFU) documentation.In doing so, you’ll set your product on a smoother path to FDA approval and subsequent market success.

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 specifications? Our template offers guidance on doing just that, including a blank chart to get started on your own user needs documentation.