Welcome to AXEON

AXEON is a firm that specializes in assisting quality-driven organizations to realize their full vision in achieving their Quality and Profitability objectives.

Specifically, we provide:

  • Lead Auditor and Customized Training Programs:

  • Consulting and Implementation Assistance

    • ISO Registration Assistance
    • AS9100 Rev D, ISO 13485:2016, ISO 9001:2015 Transition
    • Six Sigma Projects
    • Lean Manufacturing Projects
    • Continual Improvement
    • FDA Registration, 510(k), MDD, CMDR
    • NADCAP
    • Etc.
  • Auditing and Audit Preparation

    • Internal audits to ISO Standards and Regulatory Compliance
    • Medical Device Single Audit Program (MDSAP)
    • 2nd Party Audits of Supply Chain
    • Audit Consulting Assistance for 3rd Party (CB, ANAB, etc.)
  • Information Systems Integration

    • Software solutions for QMS work flow and management: CAPA, Internal Audits, Doc Control, Records Control, Supplier Control, Monitoring and Trending, etc.
    • Paperless Workflow Solutions
    • ISO 13485 and FDA, MDD, CMDR Regulatory Compliance