What services does Freyr Solutions offer?

Freyr Solutions offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Freyr Solutions specialize in?

Freyr Solutions specializes in 510k, De Novo, Pre-Submission and other FDA regulatory pathways for medical devices.

What is Freyr Solutions's regulatory experience?

Freyr Solutions has 12+ years of experience, 25+ 510(k) submissions in FDA regulatory affairs.

Freyr Solutions

Medical Device Regulatory Consulting Services

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 managem...

Experience: 12+ years

Submissions: 25 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPre-Submission

Device Specialties

NeurologyRadiologyCardiovascular

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPre-Submission

Device Specialties

NeurologyRadiologyCardiovascular

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 12+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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