IFU Builder
Write Smart. Stay Compliant.
Writing an IFU isn’t just about describing your device—it’s about navigating regulatory risk, go-to-market strategy, and submission clarity.
Completeness
Covers all FDA-required IFU elements so nothing critical gets missed.
Benchmarking
Automatically matches your device to similar cleared devices.
Regulatory Wording
Suggests language pulled from real 510(k) summaries.
IFU Builder
Write Smart. Stay Compliant.
Completeness
Covers all FDA-required IFU elements so nothing critical gets missed.
Benchmarking
Automatically matches your device to similar cleared devices.
Regulatory Wording
Suggests language pulled from real 510(k) summaries.
IFU Builder
Write Smart. Stay Compliant.
Writing an IFU isn’t just about describing your device—it’s about navigating regulatory risk, go-to-market strategy, and submission clarity.
Completeness
Covers all FDA-required IFU elements so nothing critical gets missed.
Benchmarking
Automatically matches your device to similar cleared devices.
Regulatory Wording
Suggests language pulled from real 510(k) summaries.
Ready to Get Your IFU Right?
Start building indications for use that are complete, compliant, and aligned with successful 510(k)s. Whether you're submitting your first device or refining your regulatory strategy—RegHero has your back.
Ready to Get Your IFU Right?
Start building indications for use that are complete, compliant, and aligned with successful 510(k)s. Whether you're submitting your first device or refining your regulatory strategy—RegHero has your back.
Ready to Get Your IFU Right?
Start building indications for use that are complete, compliant, and aligned with successful 510(k)s. Whether you're submitting your first device or refining your regulatory strategy—RegHero has your back.
© 2025, RegHero Inc.
© 2025, RegHero Inc.
© 2025, RegHero Inc.