Inspection-Ready PMS, MDR & Risk Systems — Built for High-Stakes Devices
Class III and other high-risk devices live or die in post-market: complaint handling, MDR decisioning, CAPA discipline, vigilance trending, field actions, and documented risk management updates. We build systems that hold up under FDA scrutiny and keep your team operational when issues hit.
Why High-Risk Post-Market Programs Break
Most post-market failures aren’t “bad outcomes”—they’re broken systems: inconsistent MDR decisions, weak complaint files, CAPAs that don’t connect to root cause, trending that happens too late, and risk files that never get updated. We help you implement a practical, audit-ready program that connects complaints → MDR → CAPA → risk management → labeling & field actions.
- MDR decisioning: consistent criteria, timelines, and documentation to support reporting decisions.
- Complaint file quality: complete investigations, device history traceability, and medical assessment pathways.
- CAPA discipline: root cause, effectiveness checks, and linkage to design/manufacturing changes.
- Risk lifecycle: ISO 14971 updates driven by real-world signals and corrective actions.
Class III PMS Programs
Structured programs you can implement fast—then defend under inspection.
PMS System Audit & Gap Closure Plan
Typical range: $4,000–$12,000
For teams needing a clear view of what will fail in an inspection—and a plan to fix it quickly.
- Review of complaints, MDR logic, CAPA, trend analysis, and risk file linkages
- Gap map with prioritized remediation steps and owners
- Document template set: complaint intake, MDR decision record, CAPA linkage
MDR & Complaint Handling Program Build
Typical range: $7,500–$25,000
For high-risk devices that need consistent decisioning, clean files, and defensible timelines.
- MDR decision tree + internal criteria aligned to your device and risk profile
- Complaint handling SOPs + investigation templates + medical assessment workflow
- Training package and “inspection-ready” recordkeeping approach
CAPA + Trending & Vigilance Program
Typical range: $9,500–$35,000+
For teams that need signals earlier, root causes faster, and effectiveness checks that actually prove closure.
- Trending framework: complaints, service, nonconformances, and real-world signals
- CAPA overhaul: root cause methods, containment, corrective/preventive actions, effectiveness checks
- Linkage to design changes, labeling updates, supplier controls, and risk files
Field Action & Recall Readiness
Typical range: $6,000–$30,000+
For companies that need a real plan for corrections/removals, communications, and traceability—before a crisis.
- Correction/removal decision framework + escalation pathways
- Communication templates (customers, distributors, internal stakeholders)
- UDI/traceability readiness: device history, lot/serial tracking, effectiveness monitoring
Who We Help
Class III Implantables
Programs where complaint quality and vigilance trending must be robust—and risk files must evolve with real-world signals.
Complex Systems & Software
Devices where software updates, cybersecurity, and field performance data must tie back to CAPA and risk management.
High-Volume Complaint Environments
Teams that need triage rules, medical assessment pathways, and scalable investigation templates.
Pre-Inspection Readiness
Companies preparing for FDA inspections (or recovering from prior observations) needing defensible systems fast.
Field Actions & Corrections
Organizations needing structured escalation, decision records, and communications for corrections/removals and recalls.
522 / PMS Expectations
Teams needing post-market study readiness and governance for high-risk device surveillance obligations.
How We Run PMS Engagements
We connect the system end-to-end so your records tell a coherent story under inspection.
Signals & Workflows
We map where signals originate (complaints, service, returns, literature, feedback) and how they flow through your system.
MDR + Complaint Files
We standardize decisioning, documentation, timelines, and investigation quality so records are consistent and defensible.
CAPA + Risk Updates
We strengthen CAPA and connect it to ISO 14971 risk management, labeling changes, and design/manufacturing controls.
Inspections & Field Actions
We prepare the inspection narrative, build recall readiness, and create escalation pathways for real-world events.
Class III PMS FAQs
What’s the #1 thing FDA looks for in complaint/MDR systems?
Consistency and documentation: clear intake, complete investigations (or justified limitations), documented MDR decisions, and evidence that trends trigger CAPA and risk updates.
Do we need to update the risk file after CAPAs?
Often, yes. CAPAs frequently indicate a change in probability/severity assumptions, new hazards, or new controls that must be reflected in ISO 14971 documentation and sometimes labeling.
What counts as a “signal” for trending?
Complaints are only one source. Service data, returns, nonconformances, supplier issues, literature, customer feedback, and cybersecurity/vulnerability reports can all be signals depending on your device and claims.
Are these pricing ranges fixed?
No—these are typical working bands. After a short triage call we provide a fixed or milestone quote based on complaint volume, system maturity, product risk profile, and whether you need build, remediation, or ongoing support.
Talk Through Your Class III PMS & Risk Program
Share your device type, complaint volume, current SOPs (if any), and whether you’re facing an inspection, an MDR backlog, or CAPA/trending issues. We’ll outline a sequenced plan with clear deliverables and a quote aligned to urgency and scope.
Based in Charleston, SC • Supporting high-risk device teams worldwide
Prefer direct email? info@verusfda.com