P3.1 Validation (Transfer to mfg)

Nothing about launching a new medical device is simple. From the FDA’s regulatory requirements to usability testing, medical device development can seem downright byzantine. Unfortunately, the [...]

Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a [...]

The last thing a medical device manufacturer wants to receive in response to their FDA filing is a “request for additional information.” It’s usually not a deal killer, but at the very least it’s [...]

After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches [...]

Seasoned medical device developers know that the FDA cares about safety and effectiveness, and nothing more. And because of the intense focus required to meet stated FDA expectations, it’s easy [...]