Axeon LLC
★★★★★
4.5
/ 5
•
11 reviews
Axeon LLC – FDA 510(k) & Regulatory Consulting | 20 Years Experience
Ron Makar from Axeon LLC is a dedicated FDA regulatory consultant with extensive expertise in 510(k) submissions and post-market surveillance. He brings 20 years of experience in guiding medical device companies through complex regulatory landscapes.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) submission support
- Companies needing expertise in ISO 13485 and related quality standards
- Organizations requiring guidance on regulatory compliance and quality system implementation
How engagement typically works
- Expert consultation and advice
- Support for certification and addressing nonconformities
- Project-based or ongoing regulatory guidance
Typical deliverables
- FDA 510(k) submission strategy and authoring
- Quality management system documentation and implementation
- Risk management and CAPA process development
- Regulatory compliance assessments
Good to know
- Best when requiring specialized FDA 510(k) expertise combined with broader quality system knowledge.
HQ:
Draper, EU
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Years Experience:
20
Num510k Submitted:
45
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consulting, Training
