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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. [...]

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 [...]

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 [...]

If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]

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 [...]