Freyr Solutions
★★★★★
4.3
/ 5
•
211 reviews
Freyr Solutions – Expert FDA Regulatory Consulting for Medical Devices
Freyr Solutions is a specialized FDA regulatory consulting firm dedicated to medical device companies. They possess significant expertise in Software as a Medical Device (SaMD) and digital health products. Their comprehensive services include detailed regulatory pathway assessments, thorough predicate device analysis, ISO 13485 Quality Management System (QMS) consulting, and ISO 14971 risk management.
About
Freyr Solutions is a specialized FDA regulatory consulting firm dedicated to medical device companies. They possess significant expertise in Software as a Medical Device (SaMD) and digital health products. Their comprehensive services include detailed regulatory pathway assessments, thorough predicate device analysis, ISO 13485 Quality Management System (QMS) consulting, and ISO 14971 risk management.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 25
- **Location:** US (Georgia)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Freyr Solutions appears to offer comprehensive regulatory consulting services for medical devices, covering the entire product lifecycle from concept to post-market. They highlight expertise in navigating regulatory ambiguity, global risk classification, and pre-submission strategies, suggesting a strong understanding of complex regulatory landscapes.
- **Unique value:** Freyr Solutions provides comprehensive support across the entire medical device regulatory journey, from initial concept to post-market activities, with a focus on navigating complex regulatory landscapes for innovative technologies.
- **Ideal projects:** The ideal client for Freyr Solutions would be a medical device company, particularly those developing novel technologies like AI-based SaMD or combination products, seeking to navigate complex regulatory pathways in multiple global markets. Companies needing assistance with regulatory strategy, risk classification, and pre-submission dialogue with regulatory bodies would also benefit.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pre-submission, de_novo, 510k-special
- **Specialties:** software-samd
- **Device panels:** neurology, radiology, cardiovascular
- **Regulatory pathways:** 510k, de_novo, pre-submission
- **Type:** independent
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 25
- **Location:** US (Georgia)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Freyr Solutions appears to offer comprehensive regulatory consulting services for medical devices, covering the entire product lifecycle from concept to post-market. They highlight expertise in navigating regulatory ambiguity, global risk classification, and pre-submission strategies, suggesting a strong understanding of complex regulatory landscapes.
- **Unique value:** Freyr Solutions provides comprehensive support across the entire medical device regulatory journey, from initial concept to post-market activities, with a focus on navigating complex regulatory landscapes for innovative technologies.
- **Ideal projects:** The ideal client for Freyr Solutions would be a medical device company, particularly those developing novel technologies like AI-based SaMD or combination products, seeking to navigate complex regulatory pathways in multiple global markets. Companies needing assistance with regulatory strategy, risk classification, and pre-submission dialogue with regulatory bodies would also benefit.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pre-submission, de_novo, 510k-special
- **Specialties:** software-samd
- **Device panels:** neurology, radiology, cardiovascular
- **Regulatory pathways:** 510k, de_novo, pre-submission
Key Highlights
- Freyr Solutions appears to offer comprehensive regulatory consulting services for medical devices, covering the entire product lifecycle from concept to post-market. They highlight expertise in navigating regulatory ambiguity, global risk classification, and pre-submission strategies, suggesting a strong understanding of complex regulatory landscapes.
- Freyr Solutions provides comprehensive support across the entire medical device regulatory journey, from initial concept to post-market activities, with a focus on navigating complex regulatory landscapes for innovative technologies.
Certifications & Trust Signals
- 12 years experience
- 25 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client for Freyr Solutions would be a medical device company, particularly those developing novel technologies like AI-based SaMD or combination products, seeking to navigate complex regulatory pathways in multiple global markets. Companies needing assistance with regulatory strategy, risk classification, and pre-submission dialogue with regulatory bodies would also benefit.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
12
Num510k Submitted:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
neurology, radiology, cardiovascular
Technology Types:
samd, ai_ml, combo_product
Accepting New Clients:
Yes
