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.

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.

The success of your medical device is contingent upon having a comprehensive project plan to guide its development. To help, access our project plan example. It’s tailored exclusively to medical devices so you can keep all of the details of development straight.

A traceability matrix helps you define and track product requirements to reduce risk and carry initial insights through to realized products. Our template and traceability matrix explainer guide will get you started.