Your Unified Regulatory Platform for Medical Devices & Diagnostics
From CE-marking and FDA 510(k) submissions to post-market surveillance and labeling updates, regulatory operations for medical devices are anything but straightforward. Each region brings its own rules, each product class brings its own challenges, and every update must be tracked with care.
Freya Fusion is a connected regulatory platform that simplifies how you manage product registrations, technical documentation, submissions, labeling, and compliance-whether you manufacture Class I devices, IVDs, SaMD, or 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 labeling.
Disconnected Teams & Systems
Design history files, submission dossiers, safety updates, and labeling 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, labeling updates, or regulatory filings requiring traceability and control.
What You Can Do with Freya Fusion
Manage Product Variants & Market Registrations
Track devices, components, accessories, indications, and intended uses across every market. Stay updated on approvals, renewals, and region-specific requirements.
Simplify Global Submissions
Support for FDA 510(k), PMA, CE-marking under MDR/IVDR, and ROW submissions-build and validate technical files, GSPRs, and STEDs with confidence.
Centralize Document Management
Secure, validated DMS for QMS records, DHF, DMR, IFUs, certificates, declarations, and more-with full audit trails and version control.
Enable Content Reuse Across Submissions
Create reusable content modules-such as device descriptions, risk assessments, and clinical data summaries-that can be tailored by product or market.
Align Labeling & IFUs
Manage global labeling variations, translations, IFUs, and packaging artwork with workflows tied directly to product and regulatory changes.
Monitor Regulatory Intelligence
Track MDR/IVDR updates, FDA guidance, notified body expectations, and emerging regulations from PMDA, ANVISA, and TGA-automatically filtered by device type or market.
Who It’s Built For!
Freya Fusion is designed for cross-functional teams working on global medical device compliance:
Regulatory Affairs & RA 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.
Labeling & 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.