Complaints · Vigilance · Signals · Field Actions
Post-Market
Surveillance
Leaders in Listening Systems That Hear
the Signal Before the Regulator Does
Leaders in Listening Systems That Hear
the Signal Before the Regulator Does
Clinical trials study thousands of patients under ideal conditions. The market studies millions under real ones, and it reports its results as complaints, adverse events, service calls, and literature. Post-market surveillance is the discipline of actually listening to that dataset: collecting it completely, reading it honestly, and acting on it fast enough that the regulator learns about problems from you rather than the other way around. We build and run those listening systems for drugs, biologics, and devices.
The complaint line is a clinical instrument. What it captures, and what it misses, defines your vigilance.
Every surveillance obligation, in every jurisdiction, is a version of the same pipeline. Regulators judge you on whether it runs completely and on time, with nothing quietly parked in between.
Complaints, adverse events, service records, literature, registries. Complete intake, one funnel, no orphaned inboxes.
Trend rules and thresholds that separate a bad week from a real signal, tuned to your volumes and risk profile.
Medical and engineering evaluation of what the signal means for benefit-risk, against the risk file you already hold.
CAPA, design change, labeling update, or field action, proportionate to the risk and defensible in hindsight.
MDRs, vigilance reports, PSURs, trend reports, filed inside clocks that do not pause while you deliberate.
Signal detection is a statistics problem wearing a compliance deadline.
Regulators increasingly cite manufacturers not for mishandling the data they had, but for never collecting the data they should have. A complete estate listens on every channel where your product leaves a trace.
The front door: intake, triage, and reportability decisions on a clock, with a record that shows each judgment.
MDRs, MIRs, and serious-incident reporting across jurisdictions, reconciled so nothing reportable dies in triage.
Systematic literature screening and registry review, on a documented cadence a notified body will ask to see.
Repair codes, returns, and installation records: the earliest and most ignored signal source for devices.
The proactive arm: post-market clinical follow-up and commitments designed to answer questions, not just exist.
MAUDE, FAERS, and recall databases read for what they say about your device class before it says it about you.
Every unit in the field is generating the data your surveillance system exists to hear.
US and EU surveillance run on different architectures with equally unforgiving clocks. We build systems that meet both from one dataset, so a global product does not need two truths.
Under EU MDR, surveillance is a designed study of your own product that never ends.
A surveillance system ultimately exists for a handful of escalating judgment calls. Each one is harder than the last, and each one is exactly where senior experience earns its keep.
The daily call. Made consistently, documented individually, and defensible when an investigator re-adjudicates your last two years of decisions.
When a familiar complaint becomes a pattern. The threshold that fires too late is a finding; the one that fires constantly gets ignored.
The signal assessed against the risk management file and the clinical evaluation, with the analysis written down while it is still a choice.
Correction, removal, or recall: the decision made with regulators watching the clock, executed cleanly, and closed with effectiveness checks.
A complaint, a trend, a class signal — each routed and escalated before it becomes a report about your device class.
Post-market judgment cannot be learned from guidance documents. Your leads have run complaint operations, chaired signal review boards, filed the reports, and managed field actions from first call to closure letter.
We have run intake queues and vigilance desks under volume, and we build systems that survive real throughput.
FDA, EU MDR/IVDR, MHRA, Health Canada, and PMDA obligations met from a single, reconciled dataset.
Trend thresholds and signal statistics set by people who understand both the math and what a notified body expects of it.
When the signal is real, we have sat in the room where the field-action call gets made, and we stay in it with you.
Post-market data flows into every corner of the quality and regulatory system. These are the services it touches first.
Every post-market signal is a test of the risk file. ISO 14971 systems that absorb field data instead of ignoring it.
Explore Risk →When a trend confirms, the corrective machinery that investigates it and closes it for good.
Explore CAPA →PMS plans, PSURs, and PMCF built into the technical documentation your notified body audits.
Explore EU MDR →Tell us about your product, your markets, and where your surveillance stands today. We’ll match you with a senior post-market lead, with a response within one business day. All inquiries are strictly confidential.
