Your AI-First Unified Regulatory Cloud
Let’s explore how freya fusion can support your medical device regulatory goals
freya fusion For Medical Devices & Diagnostics
Your AI-First Unified Regulatory Cloud
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, labeling control, and compliance adherence. It supports a wide range of medical device classifications, including Class I to III devices, in vitro diagnostics (IVDs), and software as a medical device (SaMD).
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 filings—requiring traceability and control.
How Teams Use freya fusion
freya.register
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.
freya.submit
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.
freya.intelligence
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.
freya.docs
Centralize document management with a validated DMS purpose-built for device regulatory content. Maintain DHFs, DMRs, QMS records, IFUs, certificates, and declarations — all traceable and audit-ready.
freya.automate
Accelerate submissions with content reuse. Repurpose risk assessments, clinical summaries, and technical data across multiple markets.
freya.label
Manage global labelling variations, translations, IFUs, and packaging artwork — with workflows tied directly to product and regulatory changes.
Who It’s Built For?
freya fusion is designed for cross-functional teams working on global medical device compliance:
01
Regulatory Affairs & RA Operations
Plan and manage submissions, renewals, and global registrations
02
Quality & Compliance Teams
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03
Clinical & Safety
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04
Labeling & Packaging
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05
Product Management
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06
IT & Digital Ops
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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
