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      •  

    Freya Fusion

    Via: Variation Identification Agent

    Ria: Regulatory Impact Assessment Agent

    Stay Ahead with a Unified, AI-First Regulatory Cloud

    freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML. freya fusion is a unified ecosystem that empowers RIM and covers the entire regulatory lifecycle - from registrations and submissions to labeling, artwork, intelligence, and change control. Know More

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        • Quality Control in Pharmacovigilance
        • QPPV and LPPV Services for Global PV Compliance
        • Regulatory Intelligence in Pharmacovigilance
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        • Expert Clinical and Non-Clinical Regulatory Consulting
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        • Automation in Medical Writing
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        • Creative Scientific Design Studio
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        • Our Capabilities
          • Ensuring 'Right Opportunities' for 'Right Market'
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Corrective and Preventive Action (CAPA) Management Services

  • Read more about Corrective and Preventive Action (CAPA) Management Services

Clinical & Performance Evaluation Toolkit

  • Read more about Clinical & Performance Evaluation Toolkit

Explore our expertly curated medical writing toolkit, designed to keep your medical device or In vitro diagnostic device compliant with all clinical evaluation, performance evaluation, and post-market surveillance needs.

Comprehensive Biocompatibility Compliance Services for Medical Devices

  • Read more about Comprehensive Biocompatibility Compliance Services for Medical Devices

Quality Management System Regulation

  • Read more about Quality Management System Regulation

Why should you adhere to FDA QMSR framework?

  • Regulatory Intelligence (RI)QMSR will be enforced from Feb 2. 2026, which is mandatory for manufacturers to upgrade their QMS.

Medical Device Mergers and Acquisitions Regulatory Services

  • Read more about Medical Device Mergers and Acquisitions Regulatory Services

Challenge

Freyr’s Service & How We Support

SaMD Compliance Checklist for Medical Writing

  • Read more about SaMD Compliance Checklist for Medical Writing

What’s Inside This Checklist?

Our SaMD Compliance Checklist is a practical, ready-to-use guide designed to help medical writers, Regulatory professionals, and software developers:

QMS Consultancy Services

  • Read more about QMS Consultancy Services

Corrective and Preventive Action (CAPA) Management Services

  • Read more about Corrective and Preventive Action (CAPA) Management Services

Medical Device QMS Documentation Management Services

  • Read more about Medical Device QMS Documentation Management Services

Supplier Evaluation

  • Read more about Supplier Evaluation

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How can we help you?

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