Future-Proofing SaMD: Regulatory Strategies for Medical Software Development

The rise of software as a medical device (SaMD) is transforming healthcare by enabling real-time data analysis, personalized care and predictive diagnostics. However, this promise comes with challenges. Developers must navigate evolving global regulations, address unique risks and integrate innovation without compromising safety or compliance.

SaMD is a fast-moving frontier that encompasses a wide range of software solutions. Specific uses span from artificial intelligence (AI) that predicts cardiac events to applications that monitor chronic diseases. Yet, as promising as these advancements are, the regulatory landscape often lags innovation. This leaves developers to ponder complex questions, such as:

• How can we meet regulatory requirements without stifling innovation?
• What standards apply to AI-driven updates?
• How can we streamline approvals across multiple regions?

This is where Fortrea steps in, blending a long track record of regulatory expertise with an understanding of our industry's emerging technologies to offer a road map for SaMD success. Let's explore key strategies to future-proof your medical software development, ensuring compliance, market access and long-term impact.

Defining SaMD Across Geographies

Know your terms: SaMD is recognized under varying definitions across global regulatory bodies, shaping how developers approach compliance. For instance, the FDA defines SaMD as software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.1 Meanwhile, Europe uses the term “medical device software” (MDSW) under its Medical Device Regulation (MDR), with nuanced differences in classification.

These distinctions aren't just semantic; they directly impact how products are categorized, evaluated and approved. For example, SaMD in the U.S. is divided into three risk-based classes (I-III), each of which comes with escalating regulatory demands. In contrast, Europe's MDR classifies devices into four categories (I, IIa, IIb, III), and rigorous clinical evidence is required for higher-risk classes.2

Key insight: Successful SaMD development isn’t a “one-size-fits-all” undertaking. It requires a nuanced, region-specific compliance strategy. Proactive engagement with regulatory bodies (e.g., FDA pre-submission meetings or consultations with European notified bodies) can provide you with critical guidance and prevent costly delays.

Critical Compliance Frameworks

• Risk management: Implementing ISO 14971 for systematic safety risk identification and mitigation3
• Development standards: Adhering to IEC 62304 for comprehensive software life cycle management4
• AI/ML considerations: Developing predefined change control plans to facilitate regulatory acceptance of iterative algorithmic updates
• Cybersecurity: Protecting patient data and device integrity throughout the software life cycle

By integrating these frameworks early, developers create a robust foundation for scalable, compliant innovation.

Clinical Evaluation: Your Pathway to Market

Bringing SaMD to market involves more than meeting technical specifications—You need compelling clinical evidence.

The FDA and European regulators focus on three components of clinical evaluation:

• Clinical association: Establishing scientifically validated links between software function and clinical outcomes.
• Analytical validation: Demonstrating precise performance under controlled conditions.
• Clinical validation: Providing robust real-world evidence (RWE) of intended purpose.

Example: The International Medical Device Regulators Forum (IMDRF) framework harmonizes these requirements across regions, helping developers to streamline their global submissions.5 For instance, developers leveraging IMDRF guidance can align their clinical evaluations to meet both FDA and EU MDR standards. This reduces redundancy and can help expedite agency reviews.

Lessons From a Leader in Cardiac Diagnostics: A Case Study

A global company specializing in cardiac and vascular disease diagnostics exemplifies how to navigate the complex journey of SaMD development successfully. The organization's AI-powered cardiac imaging software, designed to predict heart attack risk, faced rigorous scrutiny under Europe's MDR. Here's how they succeeded:

• Alignment to standards: Adhering to ISO 13485 and CE mark requirements
• Clinical evidence: Demonstrating the AI-assisted imaging biomarkers’ value through robust clinical validation
• Strategic planning: Coordinating a 12-month submission process that allowed them to meet regulatory milestones without compromising quality

The software now integrates advanced metrics, including inflammation markers and plaque analysis, into a comprehensive tool for risk prediction. By showcasing clinical utility and cost-effectiveness, the organization paved the way for potential reimbursement and inclusion in clinical guidelines.

This case clearly demonstrates the value of combining regulatory foresight with scientific rigor to bring innovative solutions to patients faster. Watch this webinar recording for more details on the process.

Accelerating SaMD Success With Fortrea

Our regulatory team provides unparalleled expertise to navigate SaMD's bumpy landscape. Whether you're puzzling out cybersecurity, conducting clinical evaluations or planning market access strategies, our seasoned experts deliver agile, audience-focused solutions.

Our mission is to simplify the complex so you can focus on innovation and patient outcomes. For all stakeholders, that's a win.