Premarket

Building, testing, and documenting before submission.

5 guides · 37 curated tips

What to focus on

Topics for the premarket phase

Start here. The big picture for MedTech security.

Bake security into every stage of the device lifecycle.

Identify and reason about threats before they ship.

Validate your security posture against real attackers.

Submit a cybersecurity package the FDA will accept.