EAS Consulting Group
EAS Consulting Group – Expert FDA Regulatory Consulting for Medical Devices
EAS Consulting Group is a dedicated FDA regulatory consulting firm with 15 years of experience, specializing in supporting medical device companies. They offer comprehensive services including 510(k) submission authoring, regulatory pathway assessment, ISO 13485 Quality Management System consulting, FDA mock audits, inspection readiness, and ISO 14971 risk management.
About
EAS Consulting Group is a dedicated FDA regulatory consulting firm with 15 years of experience, specializing in supporting medical device companies. They offer comprehensive services including 510(k) submission authoring, regulatory pathway assessment, ISO 13485 Quality Management System consulting, FDA mock audits, inspection readiness, and ISO 14971 risk management.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** EAS Consulting Group
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Location:** CA
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** EAS Consulting Group is a regulatory compliance solution provider specializing in FDA and USDA regulated industries. They offer consulting, submissions, auditing, training, and legal support services.
- **Unique value:** EAS Consulting Group provides comprehensive regulatory compliance solutions for FDA and USDA regulated industries.
- **Ideal projects:** Their ideal client is likely a company in the FDA or USDA regulated industries seeking expert guidance on regulatory requirements, submissions, auditing, training, or legal support.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, investigational_device_exemption, pma, de_novo
- **Specialties:** regulatory strategy, quality management systems, risk management
- **Device panels:** general_surgery, gastro_urology, orthopedic, neurology, cardiovascular
- **Regulatory pathways:** 510k, pre-submission, ide, de_novo, breakthrough_devices
- **Type:** independent
- **Company:** EAS Consulting Group
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Location:** CA
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** EAS Consulting Group is a regulatory compliance solution provider specializing in FDA and USDA regulated industries. They offer consulting, submissions, auditing, training, and legal support services.
- **Unique value:** EAS Consulting Group provides comprehensive regulatory compliance solutions for FDA and USDA regulated industries.
- **Ideal projects:** Their ideal client is likely a company in the FDA or USDA regulated industries seeking expert guidance on regulatory requirements, submissions, auditing, training, or legal support.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, investigational_device_exemption, pma, de_novo
- **Specialties:** regulatory strategy, quality management systems, risk management
- **Device panels:** general_surgery, gastro_urology, orthopedic, neurology, cardiovascular
- **Regulatory pathways:** 510k, pre-submission, ide, de_novo, breakthrough_devices
Key Highlights
- EAS Consulting Group is a regulatory compliance solution provider specializing in FDA and USDA regulated industries. They offer consulting, submissions, auditing, training, and legal support services.
- EAS Consulting Group provides comprehensive regulatory compliance solutions for FDA and USDA regulated industries.
Certifications & Trust Signals
- 15 years experience
- 45 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Their ideal client is likely a company in the FDA or USDA regulated industries seeking expert guidance on regulatory requirements, submissions, auditing, training, or legal support.
HQ:
CA
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Abbreviated 510(k), Special 510(k)
Device Types Supported:
Medical device
Years Experience:
15
Num510k Submitted:
45
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general_surgery, gastro_urology, orthopedic, neurology, cardiovascular
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, Submissions, Auditing, Training, Legal Support
