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.
About
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.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Axeon LLC
- **Years of experience:** 20
- **510(k)s submitted (self-reported):** 45
- **Regions served:** EU
- **Location:** EU (Alabama)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Ron Makar is a medical device consultant, trainer, and lead auditor at Axeon Corporation, specializing in FDA medical device regulations, ISO 9001:2015, and internal/lead auditing. He also has experience with Innovative Quality Consulting, LLC.
- **Unique value:** Ron Makar provides expertise in FDA medical device regulations, ISO standards, and auditing, offering comprehensive support for quality management and regulatory compliance.
- **Ideal projects:** The ideal client for Ron Makar would be a medical device company seeking assistance with FDA regulatory compliance, ISO 13485 implementation, quality management system development, or internal auditing.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Specialties:** risk management
- **Regulatory pathways:** 510k, post_market
- **Type:** firm
- **Company:** Axeon LLC
- **Years of experience:** 20
- **510(k)s submitted (self-reported):** 45
- **Regions served:** EU
- **Location:** EU (Alabama)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Ron Makar is a medical device consultant, trainer, and lead auditor at Axeon Corporation, specializing in FDA medical device regulations, ISO 9001:2015, and internal/lead auditing. He also has experience with Innovative Quality Consulting, LLC.
- **Unique value:** Ron Makar provides expertise in FDA medical device regulations, ISO standards, and auditing, offering comprehensive support for quality management and regulatory compliance.
- **Ideal projects:** The ideal client for Ron Makar would be a medical device company seeking assistance with FDA regulatory compliance, ISO 13485 implementation, quality management system development, or internal auditing.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Specialties:** risk management
- **Regulatory pathways:** 510k, post_market
Key Highlights
- Ron Makar is a medical device consultant, trainer, and lead auditor at Axeon Corporation, specializing in FDA medical device regulations, ISO 9001:2015, and internal/lead auditing. He also has experience with Innovative Quality Consulting, LLC.
- Ron Makar provides expertise in FDA medical device regulations, ISO standards, and auditing, offering comprehensive support for quality management and regulatory compliance.
Certifications & Trust Signals
- 20 years experience
- 45 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client for Ron Makar would be a medical device company seeking assistance with FDA regulatory compliance, ISO 13485 implementation, quality management system development, or internal auditing.
HQ:
Draper, EU
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), 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:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Engagement Models:
Consulting, Training
