Medical Device Software Validation: Meeting FDA Expectations for Embedded and Cloud Systems

Meeting FDA requirements for medical device software is essential to ensure both regulatory compliance and patient safety. This article examines strategies manufacturers can use to validate their software in  alignment with FDA standards, with attention to embedded systems and cloud-based solutions. It clarifies when software falls under regulatory oversight, whether as Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), and provides practical advice on integrating documentation and design controls into the development process. 

Medical device software falls into two main regulatory categories: 

• Software as a Medical Device (SaMD): Independent software designed for medical functions, without being integrated into a physical device. Examples include diagnostic applications and  cloud-based patient monitoring systems.   

• Software in a Medical Device (SiMD): Software embedded within a hardware medical device, such as the firmware controlling an infusion pump. 

FDA applies oversight when software performs a medical function, such as diagnosis, treatment, or monitoring. This is either independently (SaMD) or as part of a larger device (SiMD). Understanding this distinction is critical, as it determines which portions of the Quality System Regulation (21 CFR Part 820) and ISO 13485 requirements apply to development and validation. SaMD is validated as a standalone product, while SiMD validation is integrated into the overall device validation. 

Validation requirements for medical device software (embedded systems and cloud-based platforms): 

Validating medical device software requires tailored approaches for both embedded systems and cloud-based platforms. Embedded systems, such as firmware used in infusion pumps, imaging equipment, or sensor-based devices, must be validated within tightly controlled environments due to constraints like limited memory, real-time performance demands, and intricate hardware-software integration. 

On the other hand, cloud-based medical applications introduce additional complexity, particularly around cybersecurity, data integrity, and user authentication. These platforms must comply with FDA's Computer Software Assurance (CSA) framework and guidance for networked systems. Validation efforts for cloud solutions typically involve end-to-end data flow testing, rigorous verification of security and access controls, and scheduled re-validation following software updates or cloud infrastructure changes. 

Documentation expectations and design control integration with validation: 

FDA guidance emphasizes that software validation is not merely about testing. It involves a comprehensive, structured approach to ensure the system reliably meets user needs and intended uses. This process begins with well-defined, testable requirements that clearly connect user expectations to system behavior. Risk management plays a critical role to identify and mitigate potential hazards stemming from software failures. Verification and validation are central pillars. Verification ensures the software aligns with design specifications, while validation confirms it performs effectively in real-world scenarios. 

Maintaining full traceability from initial requirements through final testing is essential, especially during FDA audits. Additionally, robust change control procedures must be in place so that any software updates are thoroughly assessed for regulatory impact. FDA reviewers look for clear evidence that validation activities are integrated with design controls, demonstrating a cohesive and developed quality system where design inputs, verification efforts, and validation outcomes are tightly connected.

Arbour Group’s Expertise 

Arbour Group offers comprehensive expertise in medical device software validation, supporting manufacturers across a broad range of technologies—including embedded firmware, standalone diagnostic tools, and cloud-based support systems. Their services are fully aligned with FDA Quality System Regulation (QSR) and ISO 13485, ensuring end-to-end compliance from initial planning through audit readiness.  

Whether validating Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), Arbour Group delivers risk-based validation strategies, thorough documentation packages prepared for FDA and notified body inspections, and full lifecycle support for upgrades, patches, and system migrations. 

By integrating validation with product design and quality management, Arbour Group empowers organizataions  to meet regulatory expectations with confidence and maintain continuous compliance in an evolving technological and regulatory landscape.