Generate a complete Design History File in 30 seconds.
A profile-tailored DHF scaffold per 21 CFR 820.30, with ISO 14971 risk file and
(optionally) IEC 62304 software docs and FDA cybersecurity premarket files.
Answer 7 questions, get a ZIP of templated markdown documents ready to drop into your QMS.
⚠
This is a starter scaffold, not a substitute for regulatory advice.
Templates include TODO markers everywhere the team must fill in real content. Have
a regulatory consultant review the structure before your first formal Design Review.
1. Device profile
Used in document headers and the README.
e.g. "monitor patient cardiac rhythm during outpatient visits"
Class drives review pathway and depth of design controls.
Class I
Class II
Class III
Exempt
510(k)
De Novo
PMA
Yes
No
A: no harm. B: non-serious injury possible. C: death / serious injury possible.
Class A
Class B
Class C
Drives biocompatibility (ISO 10993) and usability (IEC 62366) scope.
Yes
No
Triggers FDA premarket cybersecurity scope (2023 guidance).