Ensuring quality, speed, and compliance in software development is critical, particularly in highly regulated industries like healthcare, finance, and aerospace. Developing medical device software, for example, presents unparalleled challenges, especially when meeting stringent Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements.
Software as a Medical Device (SaMD) organizations face numerous obstacles as they strive to meet strict standards while delivering reliable, secure, and efficient software — hurdles that often complicate the development process, potentially slowing time to market, increasing costs, or compromising quality if not effectively managed.
Here are some of the most common challenges developers encounter when implementing robust testing and compliance measures in such demanding environments:
- Regulatory Compliance: Adhering to stringent industry regulations from the FDA and EMA often requires managing risks, thorough verification, and comprehensive record-keeping throughout the software development lifecycle.
- Manual Testing Limitations: Traditional manual testing is time-consuming and resource-intensive, making it difficult to achieve comprehensive test coverage, particularly for complex scenarios.
- Low Test Coverage: Achieving sufficient test coverage can be challenging, especially when dealing with legacy systems or large codebases, which can impact software quality and compliance.
- Data Logging and Interpretation: Effective testing relies on robust logging and the ability to analyze and interpret logs to improve troubleshooting and test quality.
- Legacy Technology Constraints: Older systems may limit the ability to accelerate development, creating a need for automation to meet deadlines and evolving industry demands.
IEC 62304: More than just a regulatory requirement
That’s where the impact of the IEC 62304 standard on SaMD comes into play. By its very nature, SaMD organizations design software for medical purposes, operating independently of any physical medical device.
More than just a regulatory requirement, the IEC 62304 standard is essential for ensuring that SaMD organizations develop safe, effective, and reliable medical software. The very existence of the IEC 62304 standard has reduced the risk of software defects that could seriously harm patients.
Beyond safety, IEC 62304 provides a clear roadmap for compliant software development, covering risk management, testing, and documentation. Both the FDA and EMA use it as a benchmark for assessing medical software. For SaMD companies, IEC 62304 compliance has become an advantageous way to avoid costly delays and ensure the timely delivery of life-saving innovations.
Key approaches to meeting IEC 62304 compliance and quality standards
For SaMD developers, achieving IEC 62304 compliance and meeting regulatory requirements from the FDA, EMA, and other agencies is crucial not only for regulatory success but also for thriving in a competitive market.
Here’s a checklist of best practices every SaMD company should integrate into their medical software development approach.
- Adopt a risk-based approach by developing a plan to identify and mitigate patient safety risks through hazard analysis, design controls, and testing.
- Establish a QMS that aligns with ISO 13485, ensuring document control and meeting compliance throughout development.
- Implement an SDLC by defining requirements, applying design controls, and conducting regular reviews and testing at each stage.
- Guarantee comprehensive traceability using a matrix to link requirements to test cases, ensuring thorough testing and a solid audit trail.
- Conduct continuous verification and validation with automated testing and real-world validation to confirm software safety and performance.
- Stay informed on regulatory requirements by keeping up with FDA, EMA, and other guidelines to avoid compliance issues in your submissions.
- Perform regular audits and assessments internally and consider external audits for impartial evaluations of compliance and risk.
- Implement effective post-market surveillance by monitoring software performance, making updates, and addressing issues to maintain safety.
- Provide thorough user training and documentation that meets regulatory standards, ensuring end-users have clear guides for proper use.
- Foster engagement with regulatory bodies through ongoing communication and pre-submission meetings to clarify requirements and ease approval.
For more on the IEC 62304 standard, read our whitepaper, “How is IEC 62304 Transforming Medical Device Software Development?”
Why work with Diffblue? A case study.
Before becoming a Diffblue customer, a prominent SaMD company specializing in cancer diagnosis software faced significant challenges with manual testing, which proved too time-consuming to meet stringent FDA and EMA regulatory deadlines. Their reliance on traditional methods, especially for legacy systems, slowed their development process, hindered software quality assurance, and limited their ability to stay competitive.
By implementing Diffblue Cover, our AI unit test generation solution, the SaMD company significantly improved test coverage and operational efficiency. This shift not only accelerated development but also enhanced compliance with regulatory standards and a shortened time to market. The result was a more streamlined development process that met stringent requirements while expediting the delivery of vital medical solutions.
In just two months, Diffblue Cover boosted our customer’s code coverage by 43% and enabled them to generate 6,000 tests in under 20 minutes, allowing the company to deliver compliant software faster and with greater confidence.
For more insights, see our recently published use case, “Medical Device Software Supplier Relies on Diffblue to Ensure Compliance and Accelerate Time-to-Market.”
Can Diffblue help you?
As a SaMD developer, you’re aware that achieving precision, speed, and scalability is crucial to meeting today’s stringent regulatory standards.
And you’ve just read that Diffblue’s AI-powered unit testing software offers robust solutions for SaMD customers by enhancing comprehensive testing, traceability, documentation, risk mitigation, and efficiency — advancements that support compliance with FDA and EMA regulations while accelerating the delivery of crucial medical solutions.
So, why not take Diffblue for a test drive? Discover how Diffblue Cover can revolutionize your development process by booking a demo now.
