Medical and Health Care

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Quality Systems Excellence Achieves Zero FDA 483 Observations

Client / Setting: Medical Device Company | Cardiovascular Devices

The Challenge

Manual adverse event tracking, inconsistent complaint handling, delayed trend analysis, limited global visibility, and reactive approach to post‑market safety issues.

The Solutions

Implemented automated post‑market surveillance system with global complaint intake, adverse event database, statistical trending, regulatory reporting automation, and CAPA integration.

Key Results

  • Adverse event response time reduced from 30 to 9 days (70% improvement)
  • 100% on‑time regulatory reporting (FDA, EU, other markets)
  • Proactive issue detection prevented 3 potential recalls

Why It Matters

Validates post‑market surveillance as critical patient safety and regulatory compliance function with measurable risk reduction.

Highlights

  • Global complaint database: 50,000+ records managed
  • MDR/MAUDE automated reporting to FDA and EU authorities
  • Integration with quality management system (QMS)

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