Post-Market QMS Support That Survives Audits, Complaints, and FDA Scrutiny
After clearance/launch, the real work starts: complaints, CAPA, vigilance, supplier issues, design/labeling changes, and audits. We help you run a practical, regulator-ready post-market QMS—tight documentation, clear ownership, and a system that closes issues fast without creating new risk.
Why Post-Market QMS Programs Break
Most QMS issues aren’t “missing paperwork”—they’re missing decision logic. Inconsistent complaint triage, CAPAs that don’t address root cause, weak linkage between risk management and post-market signals, and change control that doesn’t evaluate downstream impact. We fix the system so it works under real-world pressure.
- Complaint handling gaps: unclear escalation, no triage criteria, incomplete investigations, weak trending.
- CAPA inefficiency: vague problem statements, superficial root cause, actions that don’t verify effectiveness.
- Vigilance risk: late or inconsistent reporting decisions, undocumented rationale, missing event evaluations.
- Change control risk: changes implemented without risk impact assessment, verification/validation alignment, or training closure.
Post-Market QMS Programs
Focused, post-market engagements. Choose a sprint, a system buildout, or ongoing oversight.
Post-Market QMS Triage & Remediation Plan
Typical range: $6,500–$18,000
Fast assessment of your post-market system with a prioritized, inspection-ready remediation plan.
- Document review + gap map (complaints, CAPA, vigilance, change control, audits, training)
- Risk linkage check (post-market signals → risk file updates → actions)
- 90-day plan with owners, timelines, templates, and evidence expectations
Complaint Handling + CAPA System Build
Typical range: $12,000–$45,000+
Build or overhaul the backbone of post-market: complaint intake, investigation, trending, and CAPA closure.
- Complaint SOP + forms, triage criteria, investigation framework, trending approach
- CAPA SOP + workflow, root cause tools, effectiveness checks, escalation rules
- Training roll-out + evidence package (records, metrics, dashboards as needed)
MDR / Vigilance + PMS Playbook
Typical range: $8,000–$30,000+
Decision logic and documentation that make reporting consistent, defensible, and on-time.
- Event evaluation rubric + documented rationale templates
- Reporting workflow, roles, and timing controls
- Post-market surveillance plan and periodic review cadence
Ongoing Post-Market QMS Oversight (Fractional)
Typical range: $3,500–$12,500/mo
Monthly governance so your system stays clean: trending, CAPA health, supplier issues, and audit readiness.
- Monthly quality review (complaints/CAPA/PMS metrics + action items)
- Change control + risk impact review support
- Internal audit planning support and management review inputs
Optional Add-Ons (Post-Market Only)
- Supplier quality remediation (SCARs, audits, controls, incoming inspection plans)
- Internal audit execution + corrective action tracking
- Inspection readiness package (war room binder, evidence index, mock interviews)
- Risk management refresh driven by post-market signals (linkage + updates)
What You Get
- Clean SOPs + forms/templates (not generic boilerplate)
- Decision rubrics that create consistent outcomes
- Evidence expectations spelled out (what auditors look for)
- Training records + implementation checklist
Best Fit If…
- Complaints are rising and CAPAs aren’t closing
- You’re worried about MDR/vigilance decisions
- Change control is informal or inconsistent
- An audit/inspection is coming—or just happened
Who We Help
Commercial Teams Scaling Fast
Complaint volume increases, suppliers change, and documentation lags behind growth. We stabilize the system.
Teams With Recurring CAPAs
We tighten root cause, verify effectiveness, and stop repeat issues through stronger decision logic.
Organizations Facing Audit Pressure
Internal audits, customer audits, or regulator expectations—focused remediation with clear evidence.
Supplier-Dependent Manufacturing
Incoming quality, SCAR handling, and supplier controls that actually prevent defects and escapes.
Post-Market Signal Management
Trending, periodic review, and risk linkage so issues are detected early and actioned correctly.
Change-Heavy Product Lines
Design/labeling/manufacturing changes with robust change control, verification alignment, and training closure.
How We Run Post-Market QMS Engagements
Practical, evidence-driven work that improves outcomes and reduces inspection risk.
Signal & System Review
We map your current workflows (complaints, CAPA, vigilance, change control) and identify where decisions fail.
Decision Logic
We build rubrics, SOPs, and templates that create consistent outcomes and defensible rationale.
Training & Evidence
We roll out training, establish records, and set expectations for investigations and closures.
Metrics & Review
We set up trending and periodic review so issues are detected early and CAPAs stay healthy.
Post-Market QMS FAQs
What’s the fastest way to reduce inspection risk?
Start with complaint handling and CAPA. Auditors look for clear triage, complete investigations, trending, and CAPAs that verify effectiveness. If those are weak, everything else feels unreliable.
Can you help if we already have SOPs?
Yes. Most teams have SOPs—what’s missing is a consistent decision rubric, clean templates, and evidence that the process is followed. We focus on making the system actually operate (and proving it).
Do you do ongoing monthly support?
Yes. Fractional oversight is ideal for maintaining trending, CAPA health, change control rigor, and audit readiness without hiring a full-time lead immediately.
Are these pricing ranges fixed?
These are typical bands. After a triage call we’ll provide a fixed or milestone quote based on complaint volume, CAPA backlog, audit pressure, and how much rebuilding versus tuning is needed.