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3 min read
Most QMS frameworks are built to control risk, not enable velocity for medical devices. However, software as a medical device (SaMD) moves fast, iterates often, and demands more than legacy thinking.
The medical device industry has relied on structured, hardware-focused Quality Management Systems (QMS) built around stability, control, and traceability for decades. And rightly so, those systems served their purpose. But today, we are at a critical inflection point.
Software as a Medical Device (SaMD) is not an extension of traditional devices. It's an epitome shift. And that shift is exposing a dangerous misconception: that conventional QMS models can be stretched to accommodate the unique demands of SaMD software as a medical device. In practice, they can't.
If you're applying a hardware-based medical device quality management system framework to SaMD, you're not managing quality, you're mismanaging risk.
Legacy QMS: Designed for Static, Predictable Products
The QMS frameworks most manufacturers still rely on, typically aligned with ISO 13485 and bolstered by stage-gated product development, are built for physical products. These ISO 13485 medical devices systems assume linear design cycles, long validation phases, and version stability post-market.
SaMD medical device solutions do not follow that rhythm. They are iterative, dynamic, and often cloud-based. The development lifecycle is continuous. Updates can be weekly. Risk profiles change not annually, but overnight. In this environment, a static quality management system ISO 13485 becomes a bottleneck, not a safeguard.
The Core Differences that Matter
1. Iterative Development Demands Iterative Controls
In hardware, design control is anchored to a product's physical components. Once a device is validated and released, changes are minimal and highly controlled.
SaMD software as medical device solutions, however, evolve. Each update may impact performance, safety, or clinical logic. A quality management software medical device system must enable high-frequency change control processes, integrate with agile workflows, and provide traceability across multiple software builds not just final releases.
2. Cybersecurity is a Quality Attribute
Traditional devices manage risk through physical containment and user instructions. Software as a medical device SaMD must contend with cyber threats, data breaches, and evolving interoperability requirements.
A SaMD-ready QMS embeds security into design inputs, verification protocols, and post-market surveillance. This is not a technical preference it is a regulatory expectation. The FDA's premarket cybersecurity guidance and the EU's European Medical Device Regulation requirements make this clear.
3. Post-Market is Continuous, Not Passive
For hardware, post market surveillance for SaMD often means capturing complaint data and reporting adverse events. For SaMD, post-market data is integral to product evolution.
A modern ISO 13485 QMS software system must treat real-world performance data as part of the product lifecycle. It must support real-time monitoring, automated feedback loops, and the ability to adjust clinical logic based on outcomes not once a year, but continuously.
4. Documentation Must Be Digital, Dynamic, and Decentralized
Many legacy ISO 13485 quality management system platforms rely on static documents, controlled paper trails, and manual approvals. In a software environment, this model collapses.
SaMD teams operate across geographies using cloud-based DevOps tools. Your quality management system should integrate directly with code repositories, automate traceability, and maintain documentation that updates with every sprint not every quarter.
5. Clinical Evidence Is Evolving, Not Fixed
Hardware devices validate safety and efficacy before market entry. For SaMD, premarket validation is just the beginning. Algorithms may adapt, datasets expand, and user behavior shift.
A QMS built for SaMD must support living clinical evidence. Clinical evaluation reports, usability data, and performance monitoring must evolve alongside the software. The QMS becomes an active system not just for documentation, but for decision-making.
The Misconception: Compliance is Enough
Meeting ISO 13485 or IEC 62304 is necessary. But in a SaMD context, compliance is the floor not the ceiling. Regulatory agencies are looking beyond checklists. They expect to see operational readiness to manage change, cybersecurity resilience, and real-world performance.
A traditional ISO 13485 quality management system for medical devices can be compliant and still fail to prevent risk. For SaMD, that is not acceptable. Quality must be engineered into the development process not retrofitted into static templates.
Build for the Reality of Software, Not the Comfort of Tradition
The most successful SaMD companies are not trying to fit a software as medical device product into a hardware mold. They are designing quality systems purpose-built for software development. These systems are lean, digital, integrated, and forward-looking.
If you're leading a team developing SaMD, ask yourself:
- Can your QMS handle a two-week sprint cycle?
- Does it monitor and adapt to cybersecurity threats?
- Can it track clinical performance post-release and trigger updates?
If not, the issue is not just your product. It's your system. A medical device quality management system should not constrain innovation. It should enable it securely, reliably, and at scale.
For organizations navigating this shift, partnering with experts who understand both Regulatory nuance and software dynamics like Freyr Solutions can make the difference between a system that merely complies and one that actively drives product performance and market readiness. Understanding MDR clinical evaluation requirements and maintaining compliant clinical evaluation reports becomes crucial in this evolving landscape.
To explore how your QMS can be transformed to meet the demands of SaMD, connect with Freyr Solutions Regulatory specialists today.
