Class IIa, IIb, and III device manufacturers can stop juggling templates. DocuGenius runs the full post-market surveillance documentation cycle on a single audit-traced engine.
Post-market obligations multiply with every device and every reporting period. DocuGenius regenerates PMCF plans, PSURs, and SSCPs from fresh evidence on one platform, so each required output stays current without rebuilding it by hand each cycle.
Configure once. Each annual or periodic report regenerates with new evidence.
Map each document (PMCF Plan, PSUR, SSCP, SSP) to its MDR Article 83 cadence. DocuGenius schedules the regeneration window.
Vigilance signals, complaint records, post-market clinical follow-up data - auto-classified and slotted into the right section.
Each report regenerates against your latest rules with full version history. Reviewer signs off on diffs, not blank pages.
4-in-1
PMCF, PSUR, SSCP, SSP - all from one configured ruleset.
Per-cycle
Scheduled regeneration. No reminder spreadsheets.
Versioned
Every report linked to its inputs and reviewer signoffs.
A 15-minute walkthrough on a real document — yours or ours. Pilot environment live in under a day.
QMS suites store the document. DocuGenius writes it.
DocuGenius
Generates PMCF/PSUR/SSCP/SSP drafts from configured rules.
QMS-only / manual
Stores manually-written drafts. You still write the drafts.
DocuGenius
Built-in scheduling: Class IIa annual, Class IIb/III biennial, etc.
QMS-only / manual
Calendar reminders. Spreadsheets to track who is due what.
DocuGenius
Every vigilance signal traceable from raw input to final report section.
QMS-only / manual
Document-level audit only - not signal-level.
Share your use case, we'll come prepared
What you'll get
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