Reportability determination
Every complaint is evaluated against the 30-day and 5-working-day clocks; the decision tree for death, serious injury, and malfunction is applied deterministically.
The most rigorous 21 CFR 803 filing pack a device manufacturer can send.
VigilRight assembles a documentation-complete MDR reportability and eMDR filing pack — every regulatory element, every required determination, the coded narrative, the HL7 ICSR, and the audit trail — checked against the letter of 21 CFR Part 803 before a qualified reviewer releases it.
Every subsection of 21 CFR 803IMDRF-coded device problem & health effectReportability decision tree, gate-checkedQualified RA reviewer sign-off on every pack5-business-day SLA
Why packs fail
A single missed reportable event can trigger a Warning Letter.
A medical device manufacturer's MDR compliance is only as strong as the reportability determination behind it. Miss a reportable death, serious injury, or malfunction — or file even one day late — and the FDA can issue a 483, a Warning Letter, or worse. The March 2025 BMJ study found 1.2M+ of 4.4M manufacturer reports were filed late, including over 400,000 more than six months late.
Most manufacturers run this by hand, from memory, with a small RA team drowning in complaint volume. The regulation has not been read end-to-end since the last audit. That is exactly where completeness gaps hide.
VigilRight exists to close that gap with a single, exhaustive standard applied identically to every file.
1.2M+
late MDRs identified in a single BMJ study
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 21 CFR Part 803. These are the provisions each pack is held to.
MedWatch 3500A narrative
The narrative is drafted to include all required elements: patient/event description, device details, manufacturer evaluation, and corrective action — coded with IMDRF terminology.
Electronic submission (eMDR)
All reports are filed as HL7 ICSR via the FDA Electronic Submissions Gateway; paper MDRs are never used.
Timely filing
The filing date is verified to fall within 30 calendar days (or 5 working days for remedial action) of awareness, computed deterministically.
Complaint file documentation
Every reportable event is accompanied by a defensible, audit-ready complaint file including intake records, de-duplication evidence, coding, and the signed determination.
Supplemental and follow-up reports
When new information emerges, supplemental reports are triggered and filed within the required timeframe, with the updated narrative and corrected data.
How a pack is built
Intake to qualified reviewer release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified RA reviewer signs every release. That order is never reversed.
01
Complaint Gap Scan
Upload your complaint stream (call logs, service tickets, field reports, emails, RGA records). We return a free completeness read: which complaints are potentially reportable, and what elements are missing.
02
Intake & de-duplication
As your authorized clerical agent, we intake, de-duplicate, and triage each complaint against your device family and historical MDRs.
03
Grounded coding & drafting
The IMDRF device problem and health effect codes are assigned; the 3500A narrative is drafted from validated data and the 21 CFR 803 rule pack — no legal opinions, no invented facts.
04
Deterministic completeness gates
The reportability decision tree is resolved; the filing clock is verified; the narrative is checked against all required fields; any failure blocks release.
05
Qualified reviewer release
A regulatory-affairs qualified reviewer signs the reportability determination and certifies the pack. High-severity events route to attorney review first.
06
Delivery & filing
You receive the pack: reportability determination, coded narrative, HL7 ICSR, audit trail, and filing confirmation — ready for your designated authority to certify and submit.
The bar we hold
Rigor you can measure.
100%
Qualified reviewer-released
No pack ships without a human RA signature.
5 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
4
Regulatory sources
21 CFR 803 · IMDRF · FDA MAUDE · QMSR, every applicable file.
Why VigilRight
Built to be the most thorough option a manufacturer has.
Documentation-complete, by design
The deliverable is completeness itself — every regulatory element and determination accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never make the final reportability call, give legal advice, or submit without your certification.
Engagement
Flat fee, per released pack. No contingency, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free Complaint Gap Scan before you commit — see exactly what is missing.
- One flat fee per released Reportability & eMDR Filing Pack; disclosed pass-through search fees.
- Optional fixed-fee attorney review for high-severity or complex events.
- Optional Backfile Remediation Add-on for historical complaint backlog processing.
FAQ
Questions, answered precisely.
Is VigilRight a law firm?
No. VigilRight, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for high-severity or complex events.
Do you make the final reportability determination?
No. The reportability determination is signed by a qualified RA reviewer, but the manufacturer's designated authority certifies and submits the MDR. VigilRight prepares the documentation and files on your behalf only after your certification.
What makes a pack 'complete'?
Completeness is defined by the regulation: the reportability decision tree resolved, the 30-day/5-working-day clock verified, the IMDRF codes assigned, the 3500A narrative drafted to all required fields, and the HL7 ICSR populated. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a qualified reviewer-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through search costs. No contingency and no percentage of any recovered amount or sale proceeds.
See what's missing before it costs you a Warning Letter.
Start with a free Complaint Gap Scan. Send your complaint stream and device details and we'll return a completeness read against every subsection of 21 CFR 803.
Documentation-completeness service · not legal advice · the manufacturer certifies every MDR.