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Internal & Supplier Audits

Your quality system is only as strong as your weakest supplier.

ISO 13485 Lead Auditor
Supplier Audit Expert
SCAR Management

The Challenge

Common pain points that prevent medical device manufacturers from achieving sustainable compliance.

Checkbox Exercise Audits

Internal audits feel like a "checkbox exercise" that adds no value?

Supplier Material Changes

Suppliers changing materials without notifying you, causing production failures?

Resource Constraints

Lack of resources to travel and audit your critical supply chain?

The VigilaMed Solution

Independent Audit Excellence

We act as your independent internal auditor, finding the issues your team is too close to see, and rigorously auditing your high-risk suppliers.

Manufacturing-First Methodology: Our audit approach goes beyond compliance checking—we identify systemic issues and drive real improvements in both internal processes and supplier relationships.

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What You Get

Tangible deliverables that deliver immediate value and long-term compliance.

  • Internal Audit Schedule
  • Supplier Audit Reports
  • SCAR Management
  • Audit Finding Remediation Plans
  • Supplier Qualification Framework

Ready to secure your compliance?

Schedule a consultation to discuss your specific compliance needs and how we can help you achieve audit-ready excellence.

VigilaMed

Regulatory Excellence for Device Manufacturers. Elite Quality & Regulatory consultancy specializing in ISO 13485, FDA compliance, and medical device manufacturing excellence.

ISO 13485:2016 Lead AuditorFDA 21 CFR Part 820 ExpertSix Sigma Yellow Belt10+ Years Manufacturing

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