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 [...]
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 [...]
Example Project Plan: Everything You Need to Create Your Own Medical Device Development Outline
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 [...]
Traceability Matrix Template: Translate User Needs into Actionable Design Inputs
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 [...]
