Medical Device Consulting


  • Quality System Development and Support QSR, QMSR, and ISO 13485 compliant
  • Quality System Management
  • Internal Audits
  • Supplier Audits
  • External Audit Management and Support
  • CAPA, NCMR, Complaint Management and Support
  • Regulatory Strategies – Device Classification, Regulatory Path
  • Regulatory Submissions – Pre-Sub, 510k, HDE

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Give us a call at: +1 405 227 9060 or send us a friendly email.

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