P1.2 Prescribing direction

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.

Today’s focus on VACs means that the modern market is made up of more medical device adopters — stakeholders serving as gatekeepers to market acceptance of your medical device — than ever before. [...]

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 [...]

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 [...]