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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 [...]

Downsizing and reorganization are afflicting many in this industry. Flexibility in resourcing is important as you navigate this challenging economic landscape. Supporting your development teams [...]

The FDA requires user interface specifications for medical devices. But your user interface specification can and should be more than a requirement or regulatory box to check.

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

New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that? [...]

Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design [...]