Post-market surveillance
PMS plans, trend inputs, complaint review workflows, and evidence packs that support ongoing device safety oversight.
What We Do
Device vigilance built for real post-market obligations.
Materiovigilance is the post-market surveillance system for medical devices and IVDs. PharmaRevix helps manufacturers monitor device safety, assess incidents, coordinate corrective actions, and keep authority-facing documentation current.
Incident reporting
Serious incident assessment, report preparation, timelines, and authority communication support.
FSCA / FSN coordination
Field safety corrective action planning, field safety notice drafting, distribution tracking, and closure support.
Compliance files
Procedure review, PMS documentation, periodic safety inputs, and inspection-ready evidence management.
How We Work
A structured vigilance cycle from signal intake to closure.
01 · SETUP
Map the system
Review PMS, vigilance SOPs, complaint intake, distributors, regions, and escalation routes.
02 · ASSESS
Classify events
Assess seriousness, reportability, trend thresholds, and field action triggers with documented rationale.
03 · REPORT
Coordinate authority work
Prepare incident reports, coordinate FSCA/FSN communication, and manage follow-up commitments.
04 · MAINTAIN
Keep files current
Maintain evidence, update PMS inputs, feed CAPA and risk files, and prepare for inspections or audits.
What We Deliver
Focused support for device and IVD vigilance.
PMS plan development
PMS plan review, data-source mapping, reporting cadence, and evidence structure for technical documentation updates.
PMS · PMCF input · EvidenceSerious incident reporting
Incident triage, reportability decisions, authority report drafting, timelines, and follow-up response support.
MDR · IVDR · UKCAFSCA / FSN coordination
Field safety action planning, notice preparation, communication packs, and closure documentation.
Correction · Recall · NoticeTrend and signal escalation
Complaint trending, device safety signal assessment, escalation records, and handoff into CAPA or risk management.
Trend · Signal · CAPAAuthority and notified-body readiness
Inspection preparation, evidence indexing, response support, and gap remediation for vigilance controls.
Audit · NB · InspectionStandalone or integrated support
Materiovigilance can stand alone or connect into regulatory affairs, technical documentation, and quality workflows.
RA · QMS · PVRight Fit
For device teams that need clear accountability after launch.
This page is for medical device and IVD manufacturers, importers, distributors, and virtual teams that need support after products are already in market or close to launch.
Medical devices
IVDs
EU MDR
EU IVDR
UKCA
Before MDR or IVDR scrutiny
Use PharmaRevix to pressure-test PMS, incident reporting, and FSCA readiness before authority or notified-body review.
When documentation is scattered
We organize PMS, vigilance, risk, CAPA, complaint, and authority evidence so the story is easy to defend.
During live field actions
Get structured FSCA and FSN support when timelines, stakeholders, and evidence requirements need tight coordination.
For lean internal teams
Add senior vigilance capacity without building a full in-house device safety function from day one.
Related Services
Keep device vigilance connected to the wider compliance system.
Regulatory Affairs
Strategy, submissions, technical documentation, and lifecycle support across UK, EU, US, India, and ROW markets.
Explore Regulatory AffairsPharmacovigilance & QPPV
QPPV cover, PSMF maintenance, ICSR processing, aggregate reports, signal management, and RMPs.
Explore PharmacovigilanceQMS & GAP Analysis
PV and regulatory SOPs, audit readiness, gap remediation, and inspection support across safety systems.
Explore QMSFAQ
Common questions about materiovigilance.
Quick answers for medical device and IVD teams reviewing their post-market vigilance setup.
Ask us anythingMateriovigilance is the post-market surveillance system for medical devices and IVDs. It covers monitoring, assessing, reporting, and controlling device-related safety incidents and field safety corrective actions.
Yes. PharmaRevix supports PMS planning, serious incident reporting, trend and signal escalation, FSCA/FSN coordination, and evidence preparation aligned with EU MDR, EU IVDR, UKCA, FDA, and global expectations.
Yes. We help plan the corrective action, prepare field safety notices, coordinate distribution and follow-up evidence, and maintain closure records for authority or notified-body review.
Yes. PharmaRevix can support materiovigilance as a focused standalone engagement or combine it with regulatory affairs, technical documentation, QMS, and pharmacovigilance support.
Free 30-minute consultation
Need PMS, FSCA, or device vigilance support?
Book a short call with PharmaRevix. We will help you confirm what is urgent, what can wait, and how to structure the next step.