Freyr Solutions
Freyr Life Sciences K.K.
★★★★★
4.3
/ 5
•
213 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.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) clearance.
- Companies needing assistance with eSTAR submissions.
- Firms requiring support for RTA remediation.
How engagement typically works
- Collaborative strategy development.
- End-to-end submission management.
- Expert consultation and guidance.
Typical deliverables
- Completed 510(k) submission packages.
- RTA remediation plans.
- Predicate research reports.
- Labeling review documentation.
Good to know
- Best when requiring specialized FDA regulatory expertise for medical devices.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, Predicate Research & Substantial Equivalence Strategy, 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
Supports Rta Remediation:
No
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
Supports Estar:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Engagement Models:
Project-based
