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:

  • ISO 9001:2015, AS9100:2016, ISO 13485:2016, ISO 14001:2016, OHSAS 18001, IATF 16949:2016, etc.
  • Customized Training in Quality Concepts such as:  Quality Management, Risk Based Thinking/Management, NADCAP, Process Validation, Cleanrooms, MDSAP,  FOD, Project Management, CAPA, Process Mapping, etc.
  • Cultural Change

• 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