Ensuring EU MDR Compliance: The Crucial Role of Fusion Manage in Medical Device QMS 

Learn how Fusion Manage helps medical device manufacturers meet EU MDR requirements with a flexible, cloud-based QMS that connects design, risk, and postmarket data for continuous traceability and global compliance.

Modern medical device companies increasingly rely on quality management systems (QMS) to meet evolving regulatory demands like. In this post we’ll explore how cloud-based Autodesk Fusion Manage takes quality management to the next level with configurable workflows and product lifecycle management (PLM) to help manage the entire device lifecycle—from concept and design through manufacturing, postmarket surveillance, and retirement—ensuring traceability and compliance at every stage.  

What to know about EU MDR compliance changes 

The European Union’s Medical Device Regulation (EU) 2017/745 (MDR) officially replaced the long-standing Medical Device Directive (MDD) in 2017, representing the most comprehensive regulatory overhaul in Europe’s medical-device history. 

While MDR’s intent to strengthen patient safety and transparency was clear, its rollout has been anything but simple. Compliance deadlines have been extended multiple times, and many manufacturers are still navigating legacy product extensions, notified-body bottlenecks, and a partially functional electronic system that remains under phased implementation. 

At the same time, across the Atlantic, the U.S. FDA has taken steps to harmonize its Quality System Regulation (21 CFR Part 820) with ISO 13485:2016, the very standard that underpins the MDR’s quality-system expectations. This alignment, taking effect in 2026, marks a major shift toward global regulatory convergence and could pave the way for single-audit efficiency between U.S. and EU markets. 

What does it mean for manufacturers? 

For many companies, MDR introduced a paradigm shift in how the quality system interacts with clinical, risk-management, and postmarket processes. 

Beyond ISO 13485 compliance 

ISO 13485 establishes the baseline document control, CAPA, supplier management, validation, etc., but MDR goes significantly further: 

• Clinical evaluation and postmarket clinical follow-up (PMCF): MDR requires continuous clinical evidence, not just premarket validation. 

• Postmarket surveillance (PMS): Every manufacturer must actively collect and trend field data and feed it back into risk management. 

• Traceability and transparency: Unique Device Identification (UDI) and the EUDAMED public database add layers of documentation and reporting never seen under MDD. 

• Expanded roles and accountability: Authorized Representatives, Importers, and Distributors each have explicit quality-system obligations. 

In short, MDR shifted the QMS from a “checklist for compliance” to a living ecosystem that must show continuous data feedback, vigilance, and clinical relevance. 

FDA’s alignment simplifies, but doesn’t eliminate complexity

FDA’s forthcoming Quality Management System Regulation (QMSR) aims to remove redundant or conflicting requirements between Part 820 and ISO 13485. For global manufacturers, this means fewer parallel procedures. One document-control process, one CAPA workflow, and one supplier-quality module can now satisfy both markets. 

But MDR’s expanded surveillance and clinical mandates still go beyond ISO 13485. So your QMS needs not only harmonization, but customizable adaptability to handle evolving regulatory layers. 

What do you need to change and by when? 

If you sell devices in the EU, you should already be operating under MDR principles, but the practical reality is that transitional devices are still being re-certified through 2027–2028 depending on class and legacy certification. Between now and then, expect three key areas of QMS evolution: 

Why configurable quality management systems like Fusion Manage make a difference 

Traditional, rigid QMS software often locks you into vendor-controlled configurations or slow custom-code cycles. Fusion Manage PLM with its configurable quality management processes can centralize device data, link design controls to risk files, and automate updates across the lifecycle. This supports continuous compliance and streamlines regulatory submissions. 

With Autodesk Fusion Manage, you can: 

• Configure workspaces: Adjust workflows, forms, and approval matrices directly  aligning templates to ISO 13485, FDA QMSR, and EU MDR without QMS vendor intervention. 

• Create closed-loop traceability: Link risk files, design controls, CAPAs, and PMS reports into one live digital thread. 

• Demonstrate compliance on demand: Instant trace matrices between MDR Annex II technical documentation and QMS records simplify notified-body and FDA audits. 

• Scale globally: Manage multiple regulatory frameworks (EU, US, Canada, UKCA) through configurable regions, not separate systems. 

In short: MDR’s increased documentation and feedback demands reward companies that can adapt their QMS structure quickly, something only a flexible, model-driven system like Fusion Manage makes practical. 

Manufacturers without a modern QMS 

For companies still managing MDR documentation through static tools or siloed systems, Fusion Manage offers model-driven flexibility that eliminates redundant updates and version drift. For example, templates for Technical Documentation, CAPA, and PMS plans can be dynamically linked to your device model, so a single regulatory change automatically propagates to all affected records. That adaptability transforms MDR compliance from a reactive burden into a sustainable, traceable process. 

Manufacturers already using Fusion Manage 

Teams that built their QMS on Fusion Manage are already positioned ahead of the curve. The key now is to ensure their MDR workflows incorporate the latest regulatory dependencies, linking PMS trend data to design files, updating document-change approval rules, and integrating notified-body feedback loops. Many have already achieved this seamlessly, validating that a model-based architecture was the right choice from the start. 

Looking ahead 

The convergence of EU MDR, ISO 13485, and the upcoming FDA QMSR represents a historic opportunity: the possibility of a unified global quality baseline. But achieving it depends on how agile your systems are. 

Manufacturers that can easily modify workflows, update forms, and trace data across the device lifecycle will not just stay compliant. They’ll be positioned to scale efficiently into every major market.