Insights From Our Team

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.

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

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.

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.