Services

Succeeding in today’s dynamic regulatory environment requires that each medical device or pharma business be statutorily fluent yet practical regarding their compliance/regulatory affairs and quality systems. Click on an item below to learn more about ComplianceAcuity's realistic, proven solutions in either area.

Compliance and Regulatory Affairs

  • FDA / Third-Party Audit Support
  • FDA 483, Warning Letters, Other Agency Citations
  • Liaison with Regulatory Agencies
  • Global Premarket Submissions
  • U.S. Agent
  • Adverse Event Reporting
  • Recalls and Safety Alerts
  • Ad/Promo Regulation
  • U.S. Import/Export
  • FDA Establishment Registration / Device Listings

Quality Management Systems (QMS)

  • Corrective & Preventive Action (CAPA)
  • Complaint Handling
  • Design Controls / Product Development
  • Risk Management
  • GMP Training
  • Internal/Mock Audits
  • Management Responsibility
  • Production and Process Control

Testimonials

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Our Company Golden, CO 80402, USA