Post-Market Surveillance for Medical Devices
AxiraPMS automates complaint intake, adverse event classification, literature monitoring, and regulatory report generation — so your team stops chasing data and starts acting on it.
No pricing commitment. We're building this for QA/RA teams at SME device manufacturers — early access is free.
The problem
Serious incidents must be reported within 15 days (EU MDR) or 30 days (FDA). Manual tracking in shared folders means things slip — and inspectors find them.
Your team manually checks PubMed, MAUDE, and EUDAMED on a quarterly cycle. New signals are already weeks old by the time they reach your PMS report.
Assembling a Periodic Safety Update Report from scattered complaint logs, trend data, and literature means someone's weekend disappearing before every renewal.
FDA, EU MDR, and MHRA have different timelines, templates, and terminology. Tracking multi-region obligations in a single spreadsheet is how things fall through the cracks.
"We have two people covering quality for three device lines across the EU and US. Half their time is finding information that should just be in front of them."
How it works
Complaints come in via email, web form, or your existing CRM. AxiraPMS ingests them, auto-classifies severity, and flags anything that may require regulatory notification — in real time, not at the end of the quarter.
Define your device type and indication once. AxiraPMS runs scheduled scans of PubMed, FDA MAUDE, and EU EUDAMED, surfacing new signals directly to your dashboard — with suggested relevance scores so your team reviews what matters.
Statistical trend analysis runs continuously across your complaint and adverse event data. When complaint rates deviate from baseline — or a new cluster emerges — you know before it becomes a pattern your notified body notices first.
When your reporting period closes, AxiraPMS compiles your complaint data, literature findings, trend analysis, and CAPA status into a structured report — formatted for EU MDR Annex III or FDA submission. Draft in minutes, not days.
Every review, classification, escalation, and report is timestamped and locked in an immutable log. When your notified body or the FDA comes for an inspection, your evidence file is already built.
Regulatory coverage
Post-market obligations under the updated QMSR (effective Feb 2026) and 21 CFR Parts 803, 806, and 822.
Full lifecycle support under EU MDR 2017/745 and IVDR 2017/746, including vigilance reporting obligations.
Post-market surveillance under the UK MDR framework effective June 2025, aligned with MHRA's updated reporting structure.
How it compares
| AxiraPMS | Enterprise QMS (Veeva, Sparta, TrackWise) |
Spreadsheets & Manual | |
|---|---|---|---|
| Setup time | Days | 3–12 months | Immediate (but fragile) |
| Built for SMEs | ✓ Core focus | ✗ Priced for enterprise | Sort of |
| Multi-region (FDA + EU + UK) | ✓ Day one | Add-on / configurable | ✗ Manual tracking |
| Automated literature scan | ✓ Included | Limited / manual | ✗ Fully manual |
| PSUR generation | ✓ One click | Template only | ✗ 2–4 days of work |
| Pricing | Transparent, per device line | $50k–$200k+ / year | Free but costly in time |
| Audit trail | ✓ Automatic | ✓ Yes | ✗ Manual, unreliable |
We're reaching out to QA and RA teams at SME device companies before we write a single line of code. If PMS is painful for your team, we want to hear about it.
We'll also send a free PMS compliance checklist covering FDA, EU MDR, and MHRA obligations.