When Postmarket Weaknesses Threaten Your Business — We Transform Them Into Strengths.
We partner with MedTech companies under pressure — fixing what’s broken, restoring trust, and delivering inspection-ready systems that protect your patients, your business, and your reputation.
✅ Real-world solutions, not advice
✅ CAPAs, complaints, PMS, field actions resolved
✅ Sustainable fixes that pass regulatory scrutiny
Our Services
For: Executive leaders and quality teams seeking targeted improvement or transformation of CAPA, Complaints Handling, PMS, and field actions.
We help you:
Conduct a comprehensive assessment of systems, organizations, and cross-functional processes
Identify regulatory, operational, and leadership gaps
Build a tailored roadmap that meets business and compliance goals
Deliverables:
✅ System & organization gap analysis
✅ Strategy roadmap
✅ Executive briefing deck
✅ Prioritized improvement plan
For: Medical Device companies preparing for inspections or audits (e.g. FDA, ISO 13485, MDSAP, MDR, IVDR)
We help you:
Assess readiness across CAPA, PMS, complaints, and field actions
Build an audit readiness strategy for your organization
Conduct internal audits and mock inspections
Coach SMEs and align records with auditor expectations
Deliverables:
✅ Audit readiness strategy
✅ Audit readiness playbook
✅ SME readiness training and coaching
✅ Mock audit
✅ Assessment report
For: Organizations responding to FDA 483s, Warning Letters, or other nonconformities related to CAPA, PMS, complaints, and field actions.
We help you:
• Perform gap assessments and root cause investigations
• Develop remediation plans
• Develop corrective action plans
• Develop response letters
Deliverables:
✅ Compliance gap and root cause assessment
✅ Remediation roadmap and timeline
✅ Corrective actions roadmap and timeline
✅ Regulatory response plan
For: Teams that need comprehensive trainings or role-based qualification related to CAPA, PMS, complaints, or field actions.
Each module includes:
✅ Deep dive training specific to CAPA, PMS, complaints, or field actions
✅ Regulatory requirements
✅ Role-specific training deck
✅ Case scenarios or job aids
✅ Knowledge check or qualification quiz
Available Modules:
Complaints Handling Module
MDR and Vigilance Reporting Module
CAPA Module
PMS Module
Field Actions Module
For: Teams looking to overhaul or optimize their CAPA, PMS, complaints, and field actions systems.
Each package includes:
✅ System maturity and process gap analysis
✅ Assessment and redesign of processes
✅ Redesigned workflows, SOPs, tools
✅ Training and team enablement
✅ Implementation support
Available Packages:
Complaints Handling Transformation Package: Optimize intake, triage, investigation, and escalation
Postmarket Surveillance Optimization Package: Build a proactive global PMS system that supports signal detection
CAPA System Transformation Package: Standardize CAPA triggers, risk evaluation, Investigations, action planning, and effectiveness checks
Governance & Metrics Alignment Package: Align KPIs with business and regulatory objectives; build governance forums
Procedure Optimization Package: Predefined assessment tools aligned with regulatory standards and best practices to evaluate your procedures
Field Actions Optimization Package: Optimize triggers and field action decisions, standardize regulatory language in procedures, field strategy, and communications
For: Clients who need targeted support in one or more focus areas—without committing to a full transformation package.
We help you:
Select specific services or deliverables tailored to your current priorities
Fill short-term expertise gaps without long-term contracts
Address urgent issues across CAPA, PMS, complaints, and field actions
The options below are examples. Every engagement is customized to your needs.
Targeted Options Include *:
✅ Regulatory inspection readiness and support (FDA, MDR, ISO, MDSAP)
✅ Targeted internal audit or mock inspection
✅ Single-area gap assessment (e.g., CAPA or complaints only)
✅ Root cause investigation facilitation
✅ Regulatory submission/rebuttal support (483, WL, CAPA plans)
✅ Policy/SOP development or revision
✅ SME coaching or team training sessions
How We Deliver:
Hourly or Fixed-Fee Project Engagements (scoped to deliverable)
Fast-turnaround solutions for high-priority gaps
* The listed options are examples. Every engagement is customized to your needs.
How We Work
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Project- Based Consulting
Support for targeted regulatory, quality, or audit-readiness initiatives.
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Strategic Advisory
Ongoing mentoring, training, and roadmap development.
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Remediation Strategies
Resolution of regulatory issues, including FDA warning letters, 483s, and compliance gaps, through targeted remediation strategies.
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Fractional Leadership Roles
Interim Head of Quality or Project Leadership Support
About MedVigilance Advisory & Consulting
MedVigilance Advisory & Consulting is a specialized consulting firm dedicated to helping MedTech companies navigate complex regulatory landscapes, optimize quality systems, and drive operational excellence.
With deep industry expertise and a proven track record in regulatory compliance and organizational transformation, we provide strategic advisory, system assessments, and remediation support to ensure our clients achieve and sustain compliance while improving efficiency.
Our approach is results-driven, focusing on end-to-end solutions that enhance patient safety, streamline processes, and reduce costs.
Whether addressing FDA 483s, optimizing quality systems, or looking on how to evolve to support growth, we partner with companies to deliver tailored strategies that mitigate risks and create long-term business value.
At MedVigilance Advisory & Consulting , we don’t just solve compliance challenges—we turn them into opportunities for growth, resilience, and innovation.
