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Medical Device Software Validation and Verification for Regulatory Compliance

Delve into the complexities of validation and verification for cloud-based SaMD, including regulatory considerations, key validation strategies, and best practices for compliance.
Ketryx
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September 30, 2024
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Medical Device Software Validation and Verification for Regulatory Compliance

In the realm of healthcare technology, Software as a Medical Device (SaMD) has emerged as a pivotal innovation, offering new avenues for diagnosis, treatment, and patient management. As SaMD increasingly moves to cloud platforms to leverage scalability, flexibility, and computational power, the process of validation and verification is paramount. This process ensures that SaMDs meet stringent regulatory standards, ensuring safety, reliability, and efficacy. Let’s delve into the complexities of validation and verification for cloud-based SaMD, covering regulatory considerations, key validation strategies, and best practices for compliance.

Defining Software as a Medical Device (SaMD)

First, it's essential to define what qualifies as SaMD. The International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

This category includes, but is not limited to, software that collects patient data to provide medical advice, analyze conditions, and use AI to detect abnormalities in medical images. The FDA requires that medical device manufacturers define the intended use of the SaMD, detailing its functions, specifications, and the benefits to the patient.

Understanding Medical Software Validation and Verification

What is Medical Software Validation?

Medical software validation confirms that a software product meets its intended use. This involves checking that the software fulfills user needs, mitigates risks, and complies with regulatory requirements. To validate SaMD, a comprehensive plan must be developed to test product requirements and specifications, ensuring safety and effectiveness. The process follows the V-model, a widely recognized framework seen in IEC 62304, the international standard for the lifecycle requirements for medical device software. The V-model emphasizes clear requirements and traceability between requirements and the implemented code. Validation and verification tests are conducted to confirm the software meets both technical specifications and its intended use.

Software V-model

Steps in Software Validation:

  • Create a Validation Plan: Define the entire software system, environment, assumptions, limitations, test criteria, and team responsibilities.
  • Develop Software Requirements Specification (SRS): Identify infrastructure and functional needs, including performance and security.
  • Develop a Validation Protocol: Outline expectations and testing methods through a test plan and test cases.
  • Conduct and Document Tests: Execute tests and record results.
  • Finalize Procedures and Report: Establish operational procedures and compile a final validation report.

What is Medical Software Verification?

Verification ensures that the software is built correctly and is free of defects. It involves activities such as code inspections, unit testing, and integration testing to confirm that the software functions as technically intended.

Verification Activities:

  • Code Inspections: Reviewing the code to identify and rectify defects early in the development cycle.
  • Unit Testing: Testing individual components of the software to ensure each part functions correctly.
  • Integration Testing: Ensuring that different components of the software work together seamlessly.

Medical Software Validation vs. Verification

Validation and verification, though often confused, serve distinct purposes. Validation focuses on ensuring the software fulfills its intended use and meets customer needs. On the other hand, verification involves testing at the technical level, ensuring the software meets internal requirements derived from customer needs. 

In basic terms, validation ensures that the product built meets the intended purpose, while verification ensures that the product was constructed correctly according to the specifications.

Regulatory Requirements

In the US, the FDA mandates that all medical devices undergo software validation, emphasizing documented evidence of meeting specified standards. Similarly, the EU requires compliance with regulations like the EU MDR and standards such as IEC 62304 for software life cycle processes.

FDA Requirements

The FDA provides guidelines based on the software's risk class (Class I, II, or III). Higher-risk software (i.e., Class II or III devices) requires more rigorous testing and documentation. While the FDA does not suggest specific tests, manufacturers must ensure thorough testing to comply with standards and avoid potential issues.

  • Documentation: Comprehensive documentation of the validation process, including test results and protocols.
  • Risk Management: Identification and mitigation of risks associated with software use.
  • Traceability: Ensuring that all requirements are traceable throughout the development and validation process.

EU Requirements

  • EU MDR Compliance: Adherence to the European Union Medical Device Regulation for software as a medical device.
  • IEC 62304: Compliance with the international standard for the development and maintenance of medical device software.

Challenges in Medical Software Validation and Verification

Complexity

Medical software often involves complex algorithms and integrations, making validation and verification challenging. This complexity has increased significantly with the transition from traditional embedded software to advanced cloud-based solutions. Traditionally, medical software was embedded within devices; however, the rise of cloud software has introduced layers of complexity. Modern cloud software isn't just a single function running on a device— it's a network of interconnected servers, databases, and third-party services. This intricate architecture demands meticulous validation and management.

Regulatory Changes

Keeping up with evolving regulations requires continuous updates to validation and verification processes.

Resource Intensive 

The process is resource-intensive, requiring significant time and expertise to ensure thorough validation and verification.

Dynamic Environment

The dynamic nature of software means it is constantly evolving, unlike hardware, which typically has a longer and more stable lifecycle. In the hardware domain, changes are rare and expensive, making thorough validation crucial before deployment. In contrast, software requires regular updates and maintenance to stay relevant and secure, adding another layer of complexity to its validation.

Customer Expectations

Today's customers expect timely updates and rapid responses to vulnerabilities in their software. This expectation stands in stark contrast to the static nature of hardware products, such as pacemakers, which are designed to remain unchanged over time. The ability to quickly deploy updates is essential to meet these modern demands.

Tracking Changes

A critical aspect of this approach is understanding and tracking changes between software releases. A robust system should enable developers to identify what tests need to be rerun, especially when addressing critical bugs that require immediate fixes. This is particularly challenging when different versions or variants of the software exist, each tailored to specific markets or regions.

Moving Beyond Document-Based Systems 

Traditional document-based approaches often fall short in dynamic and fast-paced medical software development environments. Instead, an item-based or object-oriented approach, where individual software components are tracked and validated, proves more efficient. This method allows for precise tracking and validation of changes, ensuring compliance without the cumbersome process of managing extensive documentation.

How to Manage the Complexity of Medical Device Software Validation 

As software evolves, its complexity increases, making validation an ongoing challenge. Effective strategies include maintaining detailed requirement architectures and design documents, ensuring that all changes are thoroughly tested. Automated tests play a crucial role but must be balanced with practical considerations to avoid overly lengthy testing cycles. 

In the software domain, traditional waterfall development models, which involve lengthy phases of requirement gathering, building, and testing, are no longer viable. Agile development methodologies, which promote iterative and incremental development, are essential for keeping pace with the rapid evolution of software.

The Importance of a Risk-Based Approach in SaMD Validation

In the realm of cloud-based medical software, adopting a risk-based approach is crucial for ensuring patient safety and regulatory compliance. This method involves identifying and assessing potential risks in the software architecture, followed by implementing appropriate risk controls.

When a part of the software is identified as high-risk, a thorough risk assessment is conducted. This process involves determining hazardous situations and implementing risk controls to mitigate unacceptable risks. These controls could range from specific software requirements to functions that prevent certain failure conditions. Regular testing ensures these controls remain effective with each new software release.

With each software update or release, it is vital to retest all risk controls to ensure they haven't been compromised. This continuous validation process is a cornerstone of maintaining software safety and effectiveness. The FDA emphasizes this risk-based approach, which integrates risk considerations throughout the software development lifecycle.

Common Pitfalls for SaMD Validation 

Some of the biggest challenges in the industry are the uncertainty and delays associated with ensuring all requirements and validations are in place before a release. This uncertainty can slow down the development process, impacting the timely release of potentially life-saving medical software.

Companies often resort to manual processes to track changes and validations, which can be time-consuming and error-prone. 

Understanding Cloud Validation in the SaMD Ecosystem

Cloud validation for SaMD refers to the process of ensuring that both the software and its cloud-based infrastructure are designed, deployed, and maintained according to regulatory requirements and industry standards. This involves rigorous testing and documentation to verify that the SaMD performs as intended in the cloud environment, maintaining data integrity, security, and privacy.

Validating cloud-based medical software involves navigating numerous dependencies and ensuring every component functions correctly. Unlike the more static embedded systems, cloud software is dynamic, with frequent updates and changes driven by evolving dependencies and security vulnerabilities. This fluid nature necessitates a robust and continuous validation process.

Key Components of Cloud Validation for Medical Software

Cloud validation for SaMD encompasses several critical components, each addressing different aspects of software and infrastructure integrity:

Infrastructure Qualification

Manufacturers must ensure the cloud infrastructure (e.g., servers, storage, network) meets all requirements for reliability, security, and privacy. This involves validating physical and virtual security measures, data encryption, and backup systems.

Software Validation

Manufacturers must confirm that the SaMD functions correctly and safely within the cloud environment, meeting all specified requirements. This includes extensive testing of software features, performance under different conditions, and integration with other systems.

Data Integrity and Security

Verifying that data within the SaMD ecosystem is accurately and securely managed, with robust encryption, access controls, and audit trails is necessary. Compliance with standards such as HIPAA in the U.S. and GDPR in Europe is critical.

Operational Qualification

Manufacturers must demonstrate that the SaMD operates effectively within its intended environment, including the ability to withstand various loads and perform reliably over time.

Performance Qualification

Validation that the SaMD meets all user needs and regulatory requirements in real-world scenarios, focusing on user experience, data analysis accuracy, and overall system performance, is crucial.

Best Practices for Cloud Validation

Achieving compliance and ensuring the effectiveness of cloud-based SaMD requires adherence to best practices throughout the validation process:

  • Comprehensive Documentation: Maintain detailed records of all validation activities and results, providing a clear audit trail for regulatory review.
  • Risk Management: Implement a systematic approach to risk assessment and mitigation, addressing potential security vulnerabilities and performance issues in line with ISO 14971, the standard for application of risk management to medical devices.
  • Continuous Monitoring and Improvement: Regularly review and update cloud-based SaMD systems to address emerging threats, technological advancements, and regulatory changes.
  • Collaboration with Cloud Service Providers: Work closely with providers to ensure that their services and support align with regulatory requirements and validation objectives.

The Role of Ketryx in Medical Software Validation and Verification

Ketryx addresses validation and verification for SaMD challenges by allowing teams to continue using their preferred tools, such as GitHub, Jira, and AWS, while maintaining compliance in the background. Ketryx captures necessary data for regulatory bodies like the FDA, ensuring that every change and its validation are meticulously tracked. This approach combines the flexibility of modern development tools with the assurance of compliance.

Ensuring Robust Risk Controls

Ketryx excels in helping companies implement and maintain risk controls throughout the software development lifecycle. Every time a new release or change is made, Ketryx ensures that all associated risk controls are tested and intact. This continuous validation process is crucial for compliance with FDA regulations, which emphasize a risk-based approach to software validation.

Seamless Integration with Existing Tools

One of the key strengths of Ketryx is its ability to integrate seamlessly with tools that developers already use, such as GitHub, AWS, and Jira. This integration allows developers to continue their workflow without disruption while Ketryx works to maintain compliance and track necessary data. This ensures that all code changes, approvals, and associated documentation are captured accurately.

Comprehensive Traceability

Organizations are able to see links between items at a glance through an easy-to-digest traceability matrix. Ketryx surfaces any traceability gaps, ensuring that all requirements are traced to the appropriate specifications, risks, and tests.

Audit Trails

Ketryx provides detailed tracking of every change made in the system, including who made the change, who approved it, and the nature of the change. In this way, Ketryx automates the generation of Part 11-compliant audit trails. Ketryx allows users to go back and view the state of any item at any point in time, guaranteeing that all changes are documented and compliant with regulatory requirements.

Efficient Handling of Post-Market Complaints

Managing post-market complaints and anomalies is a critical aspect of medical software compliance. Ketryx simplifies this process by linking complaints to specific items in the software architecture. This traceability helps identify the root cause of issues and certifies that fixes are properly tracked and documented. It also ensures that all relevant information, such as the version affected and the resolution timeline, is easily accessible.

Moving Beyond Document-Based Systems

Traditional document-based approaches can be cumbersome and inefficient, particularly in dynamic and fast-paced development environments. Ketryx adopts an item-based approach, where each piece of information is treated as an individual item that can be tracked and managed more effectively. This approach allows for more precise validation and easier management of changes over time.

Enhanced Validation and Compliance

Ketryx supports the validation of external services in cloud environments by integrating continuous integration and continuous deployment (CI/CD) jobs, such as automated testing. These jobs run regular checks on external services, ensuring they perform as expected. This is critical for maintaining the reliability and performance of software in cloud environments, where external dependencies play a significant role.

SaMD Validation and Verification Interview

For the benefit of our readers, we have included and abridged transcript of the interview conducted on the topic of SaMD validation and verification with Ketryx’s subject matter experts: Jan Pöschko and Patrick Ecker.

Interview transcript