The software running medical devices aren't just lines of code — they’re a lifeline for patients. So, as companies innovate in their development of Software as a Medical Device (SaMD), the stakes have never been higher.
Today, SaMD can diagnose conditions, suggest treatments, and inform clinical management. However, as software plays an increasingly vital role in medical devices, the risks associated with software failures can have serious consequences.
That’s where the impact of the IEC 62304 standard on SaMD comes in. More than just a regulatory checkbox, IEC 62304 is an international standard that forms the foundation for developing safe, effective, and reliable medical software.
By following these standards, companies can significantly reduce the chances of software defects that could potentially harm patients.
It’s not just about patient safety, however. IEC 62304 provides a clear, compliant roadmap that guides companies through the essential processes of software development, from risk management to rigorous testing and documentation. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) rely on IEC 62304 as a benchmark for assessing whether medical software is up to par. For SaMD organizations, skipping or circumventing compliance isn’t an option; it leads to costly delays and potential setbacks.
In short, adhering to IEC 62304 not only helps protect patients but also streamlines the path to market, ensuring that innovative medical products can reach those who need them most without delay.
Before diving deeper into how IEC 62304 impacts SaMD development, let’s first break down this standard and why it matters.
What is the IEC 62304 standard?
IEC 62304 sets the guidelines for developing medical software, particularly for companies working with Software as a Medical Device. Recognized worldwide, this standard is necessary because it lays out the essential steps and practices needed to make sure that medical software is safe, reliable, and meets regulatory requirements.
Here’s what you need to know about how IEC 62304 helps SaMD solutions meet industry expectations and regulatory demands:
- IEC 62304 covers the entire software development lifecycle. From the initial concept to the eventual retirement of the software, the IEC 62304 standard provides a structured framework that includes everything from design and development to testing, maintenance, and documentation.
- IEC 62304 focuses on risk management. IEC 62304 requires that companies identify and address potential risks associated with medical software throughout the development process. This helps guarantee that any possible hazards are identified early, assessed thoroughly, and controlled effectively.
- IEC 62304 categorizes software by degree of failure. The level of rigor in development increases with the software’s classification, meaning that more stringent processes are required for higher-risk software. If the software fails for any reason, it is classified as one of the following:
- Class A: No injury or damage to health is possible.
- Class B: Non-serious injury is possible.
- Class C: Death or serious injury is possible.
- IEC 62304 mandates comprehensive documentation. This includes everything from the initial requirements and design records to detailed test plans and risk management logs, assuring that all aspects of development are thoroughly documented and traceable.
- IEC 62304 stresses post-market oversight. The IEC 62304 standard emphasizes the importance of ongoing software maintenance and post-market surveillance. This involves managing updates, fixing bugs, and continuously monitoring the software’s performance after release to confirm it remains safe and compliant with all relevant standards.
Ten strategies to meet IEC 62304 compliance and quality standards
For SaMD developers, meeting IEC 62304 and satisfying regulatory demands from the FDA, EMA, and other agencies isn’t just necessary — it’s the key to success in a highly competitive market.
Here are ten best practices that SaMD companies should follow:
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Embrace a Risk-Based Approach
- Start by developing a detailed risk management plan early in the process. This plan should focus on identifying and assessing potential risks, particularly those that could compromise patient safety.
As you evaluate each software component, conduct thorough hazard analyses to uncover risks. Once identified, mitigate these risks through careful design controls, rigorous testing, and validation procedures.
- Start by developing a detailed risk management plan early in the process. This plan should focus on identifying and assessing potential risks, particularly those that could compromise patient safety.
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Implement a Quality Management System (QMS)
- To meet IEC 62304 and FDA requirements, your Quality Management System should align with ISO 13485. This standard offers a solid framework for documenting processes, managing risks, and maintaining product quality throughout the software development lifecycle.
Additionally, make sure that your document control procedures are stringent, keeping thorough records of changes, approvals, and revisions during development and testing.
- To meet IEC 62304 and FDA requirements, your Quality Management System should align with ISO 13485. This standard offers a solid framework for documenting processes, managing risks, and maintaining product quality throughout the software development lifecycle.
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Follow a Structured Software Development Lifecycle (SDLC)
- Begin by clearly defining all software requirements throughout the entire development process. These should include functional, performance, and safety requirements. Next, design controls should be implemented to guarantee that the software design consistently meets these specifications, and design documentation should be regularly reviewed and updated as changes occur.
Regular code reviews should be conducted alongside thorough testing at each stage of development. This should encompass unit, integration, and system testing to verify that the software meets its requirements and functions as intended.
- Begin by clearly defining all software requirements throughout the entire development process. These should include functional, performance, and safety requirements. Next, design controls should be implemented to guarantee that the software design consistently meets these specifications, and design documentation should be regularly reviewed and updated as changes occur.
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Ensure Traceability
- Establishing end-to-end traceability is essential for demonstrating compliance and preparing for future audits. This means maintaining clear connections from initial requirements through to design, implementation, testing, and deployment.
To facilitate this, utilize a traceability matrix to map each requirement to its corresponding test cases, providing that every requirement is thoroughly tested and validated. This comprehensive approach helps guarantee that all aspects of the software meet the necessary standards and provides a robust audit trail.
- Establishing end-to-end traceability is essential for demonstrating compliance and preparing for future audits. This means maintaining clear connections from initial requirements through to design, implementation, testing, and deployment.
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Engage in Continuous Verification and Validation
- Leverage automated testing solutions to enhance efficiency and coverage, especially for unit testing. This will help you ensure that tests are repeatable and consistent across various software versions, and are maintained after every code change.
Additionally, it’s crucial to conduct validation activities that simulate real-world scenarios. This approach verifies that the software performs safely and effectively in the environments where it will be used.
- Leverage automated testing solutions to enhance efficiency and coverage, especially for unit testing. This will help you ensure that tests are repeatable and consistent across various software versions, and are maintained after every code change.
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Maintain Regulatory Awareness
- Staying informed about the latest regulations, guidelines, and standards from the FDA, EMA, and other relevant bodies is important for ongoing compliance. As regulations for SaMD continue to evolve, keeping up-to-date keeps your practices aligned with current requirements.
You’ll want to make sure that all regulatory submissions — such as software documentation, risk management files, and validation reports — meet the specific criteria set by regulatory agencies. This proactive approach helps avoid compliance issues and facilitates smoother regulatory processes.
- Staying informed about the latest regulations, guidelines, and standards from the FDA, EMA, and other relevant bodies is important for ongoing compliance. As regulations for SaMD continue to evolve, keeping up-to-date keeps your practices aligned with current requirements.
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Conduct Regular Audits and Assessments
- Regular internal audits are necessary for evaluating compliance with IEC 62304, ISO 13485, and other relevant standards. Use these audits to find areas for improvement and be confident that your processes remain effective and compliant.
Consider engaging external auditors or consultants to objectively assess your processes and software. These third-party reviews provide valuable insights into compliance and risk management, helping maintain high standards and address potential issues.
- Regular internal audits are necessary for evaluating compliance with IEC 62304, ISO 13485, and other relevant standards. Use these audits to find areas for improvement and be confident that your processes remain effective and compliant.
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Post-Market Surveillance
- After releasing your software, you’ll want to implement a robust post-market surveillance process. This involves monitoring the software’s performance by collecting and analyzing data on its usage, performance, and any reported issues or adverse events.
Based on these insights, continuously update the software to resolve any identified problems or vulnerabilities. This allows you to ensure that all changes are thoroughly tested and documented to meet regulatory requirements, keeping the software effective and safe over time.
- After releasing your software, you’ll want to implement a robust post-market surveillance process. This involves monitoring the software’s performance by collecting and analyzing data on its usage, performance, and any reported issues or adverse events.
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User Training and Documentation
- Providing clear and detailed documentation is essential for end-users, including instructions for use, installation guides, and troubleshooting information. Ensure this documentation adheres to regulatory standards to facilitate proper use and compliance.
Also, be sure to offer comprehensive training programs for healthcare professionals and other users. These programs should focus on helping users understand how to operate the software safely and effectively, improving overall usability and reducing the risk of misuse.
- Providing clear and detailed documentation is essential for end-users, including instructions for use, installation guides, and troubleshooting information. Ensure this documentation adheres to regulatory standards to facilitate proper use and compliance.
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Engage with Regulatory Bodies
- Foster early and regular communication with regulatory bodies throughout the software development process. Engage with them from the start and maintain open lines of communication to address any concerns and seek guidance as needed.
Schedule pre-submission meetings with the FDA or other relevant agencies. These meetings can clarify requirements, provide valuable feedback on your compliance approach, and result in a smoother regulatory process.
By following these best practices, SaMD companies can better navigate the complex regulatory landscape and be certain that their software meets the high standards for patient safety and regulatory approval.
- Foster early and regular communication with regulatory bodies throughout the software development process. Engage with them from the start and maintain open lines of communication to address any concerns and seek guidance as needed.
Accelerate SaMD quality and compliance with autonomous AI unit test writing from Diffblue Cover
AI-driven test automation can significantly aid companies in achieving and maintaining compliance with IEC 62304. By increasing testing coverage and significantly improving code quality Diffblue Cover helps promote adherence to rigorous compliance and safety standards.
Diffblue Cover offers key features to accelerate development and provide the proof and traceability needed to meet these standards:
Automated Unit Testing
- Enhanced Code Coverage: Diffblue Cover automates the creation of unit tests, significantly improving code coverage — an important requirement for IEC 62304 compliance. Higher code coverage ensures that more code is tested, reducing the risk of untested paths that could lead to failures.
- Seamless Continuous Testing: Integrating Diffblue into continuous integration (CI) pipelines allows for automatic testing of every code change. This continuous approach helps maintain compliance with IEC 62304 by focusing on rigorous and consistent evaluation.
Traceability and Documentation
- Precise Test Cases: Diffblue’s AI-driven test generation links test cases directly to specific code segments. This capability helps maintain the detailed documentation and traceability required by IEC 62304 and provides clear evidence of compliance.
- Automated Reporting: Diffblue produces comprehensive reports that highlight which code segments are covered by tests. These automated reports support the documentation and evidence requirements of IEC 62304, providing clear, organized proof of testing coverage.
Risk Management
- Efficient Automated Regression Testing: IEC 62304 highlights the importance of risk management and mitigation. Diffblue’s automated regression testing quickly identifies issues and regressions after code changes. This rapid detection helps minimize the risk of introducing new defects into medical device software, improving overall safety and reliability.
Efficiency and Compliance
- Cost and Time Reduction: By automating the testing process, Diffblue decreases the time and expense involved in manual testing. This efficiency frees up resources, enabling companies to focus more on other crucial areas of IEC 62304 compliance, such as risk management and documentation, and ultimately streamlines the entire compliance process.
Quality Assurance
- Improved Code Quality: Diffblue improves software quality by providing comprehensive code testing and detecting bugs early in development. This proactive approach supports meeting the high-quality standards required by IEC 62304.
The bottom line is that Diffblue not only ensures that companies meet the stringent regulations set by the FDA and EU regulators but also equips SaMD organizations with the tools to excel. By enhancing precision, accelerating development, and scaling operations, Diffblue helps these organizations stay competitive in a rapidly evolving market.
Book a demo now
Book a demo with one of our experts today to see how Diffblue can help you improve quality, build new software faster, and confirm the safety and effectiveness of your medical software.
