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

👉 Book Your Strategy Call 

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

👉 Schedule Your Audit Readiness Consult

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

👉 Request a Custom Remediation Quote

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

👉 Book a Training Demo

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

👉 Explore Available Packages

 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

👉 Request a Custom Quote

* The listed options are examples. Every engagement is customized to your needs.

Contact us

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