Postmarket compliance doesn't pause after clearance. MSI automates the internal audits, surveillance, and reporting that usually eat weeks of your team's time — tracking adverse events, field actions, and recalls, and drafting the audit from evidence already in the platform.
AI auto-complete answers audit questions from the documentation you've already linked — review and summarize instead of starting from a blank form.
Adverse events, field actions, and recalls tracked in one register, so postmarket signals live in one place instead of scattered inboxes.
The audit reflects today's portfolio, not last year's snapshot. Every device carries its own up-to-date status.
Pulling engineers off product to assemble an audit is the expensive way to stay compliant. Automation hands those weeks back.
Section 524B made surveillance ongoing. A once-a-year scramble doesn't satisfy a requirement that never pauses.
Surfacing gaps continuously means audit time is a confirmation, not a discovery — and never an emergency.
The platform pulls from your device registry, assessments, and collections, so the audit draws on what you already maintain.
AI auto-complete drafts answers against your framework; your team reviews, edits, and approves.
Log adverse events, field actions, and recalls, and feed them back into the compliance record as they happen.
Adverse events, field actions, and recalls captured in a single register, mapped to the devices they affect.
Maturity and audit answers drafted from your linked evidence, with built-in review and summarization before anything is finalized.
Each device carries its own current maturity, audit, and surveillance status — a living record, not a stale annual file.
Verified, Unverified, and Justified grounding on every audit answer, so each one can be backed up when a regulator asks.
Postmarket is where unresolved gaps resurface as deficiencies. MSI runs your self-audits against how the regulation is actually enforced — informed by proprietary data on what FDA is catching after clearance, by a team that includes former FDA CDRH reviewers and authors of the guidance itself.
Former FDA CDRH reviewers · Postmarket surveillance · Adverse events / field actions / recalls · Section 524B aligned · Lifecycle maintained
One pass on your real portfolio. The surveillance organized, the audit drafted, the team out of the fire drill.
Run a self-audit