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:
- ISO 9001:2015, AS9100:2016, ISO 13485:2016, ISO 14001:2016, OHSAS 18001, IATF 1694:2016, 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
- 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
- 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