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

Who It’s Built For!

Freya Fusion is designed for cross-functional teams working on global medical device compliance:
Freya Fusion

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

Freya Fusion Bot

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.

Let’s explore how Freya Fusion can support your medical device regulatory goals.

Schedule a Live Demo