fusion:
For Medical Devices & Diagnostics
Your AI-First Unified Regulatory Cloud Platform
freya fusion is a comprehensive, connected regulatory platform designed to simplify the management of medical device regulatory operations. This platform offers a unified solution for product registrations, technical documentation, submission processes, labelling control, and compliance adherence. It supports a wide range of medical device classifications, including Class I to III devices, in vitro diagnostics (IVDs), software as a medical device (SaMD), and complex Class III combination products.
Why Medical Device Regulatory Operations Are So Challenging?
Ever-Evolving Global Regulations
Staying compliant with MDR, IVDR, FDA 21 CFR Part 820, TGA, Health Canada, and other regulatory frameworks requires continuous tracking and quick adaptation.
Complex Product Variants & Markets
Devices often have multiple SKUs, configurations, and intended uses-each requiring region-specific tracking, documentation, and labelling.
Disconnected Teams & Systems
Design history files, submission dossiers, safety updates, and labelling changes are often scattered across teams and tools-creating silos, delays, and audit risks.
High Documentation & Change Control Burden
Each change to a component, indication, or manufacturing site may trigger new impact assessments, labelling updates, or regulatory filing-requiring traceability and control.
What You Can Do with freya fusion?
Manage product variants & market registrations to track devices, components, accessories, indications, and intended uses across every market. Stay updated on approvals, renewals, and region-specific requirements.
Simplify global submissions confidently to build, validate, and submit technical documentation across global markets. Support for FDA 510(k), PMA, CE-marking under MDR/IVDR, and Rest-of-World submissions - including Technical Files, GSPRs, STEDs.
Centralize document management with a validated DMS purpose-built for device regulatory content. Manage QMS records, DHF, DMR, IFUs, certificates, declarations, and more - with full version control and audit trails.
Enable content reuse & accelerate submissions to turn repeatable tasks into reusable modules across global markets. Reuse device descriptions, risk assessments, clinical data summaries, and more - tailored by product or market.
Monitor global regulatory intelligence and stay ahead of changing regulations and expectations. Track MDR/IVDR updates, FDA guidance, notified body expectations, and emerging regulations from PMDA, ANVISA, TGA - automatically filtered by device type or market.
Manage global labelling variations, translations, IFUs, and packaging artwork - with workflows tied directly to product and regulatory changes.
Who Is freya fusion Built For?
freya fusion is designed for cross-functional teams working on global medical device compliance:
Regulatory Affairs & Regulatory Operations
Plan and manage submissions, renewals, and global registrations
Quality & Compliance Teams
Maintain document traceability and audit readiness
Clinical & Safety
Monitor post-market requirements, safety reporting, and surveillance triggers
Labelling & Packaging
Update labels and IFUs across SKUs and countries
Product Management
Track product lifecycles, variants, and regional status
IT & Digital Ops
Ensure security, validation, and integration with QMS/RIMS systems
Why Device Manufacturers Trust Freya Fusion?
Ensure compliance with MDR, IVDR, FDA, and global standards
Reduce delays from disconnected workflows and scattered documents
Reuse data and documents intelligently across submissions
Stay prepared for audits, inspections, and notified body reviews
Manage all device information-from design to post-market-in one place
Be Audit-Ready, Market-Ready, and Future-Ready
Whether you’re launching a new SaMD, managing Class III renewals, or navigating MDR compliance for legacy products-freya fusion gives you full control over your regulatory ecosystem.