Manufacture in a compliant fashion.

We answer questions, diagnose, and fix quality problems. Our team performs mock audits and assesses QMS compliance against various regulatory authorities including FDA Part 820, the EU MDR, MDSAP, and ISO 13485:2016. We help with design transfer, production setup, and supply operations.

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Representative matters:

  • QMS administration, audits, remediation
  • CAPA process facilitation
  • MDR
  • Adverse event reporting
  • Form 2253 submission
  • Risk Management
  • Design controls, product development, and DHF remediation
  • Statistical techniques
  • Mock inspections
  • FDA meetings
  • Crisis management
  • Recall assessment, strategy and management
  • Part 806 corrections and removals
  • Health Hazard Evaluations
  • Process development, validation, and remediation
  • Facility planning and moves
  • Design transfer
  • Supply chain audits and qualification
  • Project management