Who it is for

Device makers preparing a premarket submission who would rather find the holes now than have a reviewer find them later.

What you get

• A threat model of the device, its app, its firmware, and its cloud middleware.
• A findings report with concrete fixes, prioritized by exploitability and patient impact.
• A hardened design you can hand to your filing consultants with confidence, before you spend the $80K on the filing itself.

How it runs

Duration: 4 to 8 weeks. We work inside your quality system and leave the documentation in a form your regulatory team can reuse.

Related

Medical Devices covers device, app, firmware, and cloud development.