Whitepaper: Static Analysis for FDA Software Validation Compliance

The FDA has publicly recommended that software developers use static analysis for ensuring medical device software safety and reliability. Adopt static analysis for an integrated, comprehensive compliance process.

Learn how to use static analysis capabilities to accomplish FDA compliance.



Download the whitepaper to get the details on how to use static analysis to bolster your FDA compliance efforts, plus information on software solutions for medical device software development.

Key takeaways:

  • Challenges of adopting FDA recommended software development approach
  • Overcoming lack of software development policy
  • Benefits of a continuous static analysis process
  • Maintaining relevant, meaningful results
  • Sustaining static analysis using process and workflow
  • Beyond static analysis: critical software lifecycle and risk-management activities
  • The role of policy and workflow management/optimization
  • At the same time, static analysis is only one piece of the software development puzzle. The FDA also recommends medical device software development teams take a software development lifecycle (SDLC) approach, integrating risk management strategies with principles for software validation.
  • An integrated SDLC merges validation and verification activities, including unit testing, peer code reviews, static analysis, manual testing, and regression testing. The result is an emphasis on planning, verification, testing, traceability and configuration management.
  • The problem is this: even with the ideal mixture of testing techniques, quality software can’t be delivered by testing alone. Rather, a solid, repeatable process is required, encompassing software testing and analysis, quality planning, requirements traceability, and change management.
  • Parasoft static analysis capabilities support FDA compliance initiatives. Additionally, Parasoft offers a broader software solution for medical devices software development so organizations can procure medical device software consistently, efficiently and without unacceptable risks.

This is primarily due to the vague nature of FDA compliance guidelines. The FDA guidance the concept of the Least Burdensome Approach – not specific practices. Organizations control and stringently adhere to self-defined validation and verification processes.

The goal is to give medical device makers the flexibility to determine how to best ensure public safety. Development activities and outcomes must be clearly defined, documented, verified and validated against the organization’s process.

For some organizations, compliance burdens have only increased. The organization is responsible for validating and verifying software with extensive testing and developing the basis upon which software is considered safe for use at the same time.

The best way to overcome these challenges while satisfying the FDA’s requirements for medical device software development is to operate the development process within a platform based on policy-driven development.

Policy-driven development involves:

  1. Clearly defining expectations and documenting them in understandable policies
  2. Training engineers on the business objectives driving those policies

Monitoring policy adherence in an automated, unobtrusive way

  1. Developers adopt better coding habits that help them write better code, faster.
  1. Developers remediate problems faster and easier.

Use static analysis to monitor a non-negotiable set of expectations around code reliability, security, performance, and maintainability. With this approach, a violation of a guideline is not just another suggestion for people building software in an ivory tower, but a notification that the code failed to meet the organization’s expectations. 

Policy management lies at the core. Parasoft allows you to easily configure policies for specific projects without compromising the integrity of the corporate objectives.

A carefully defined and implemented set of policies establishes a knowledge base that guides developers to start writing safe and reliable code as a matter of habit.

With a policy established, putting it into practice involves workflow management: defining, automating and monitoring a workflow that improves development productivity and forms the foundation for a sustainable process.

Extending beyond the test and analysis component of compliance, Parasoft supports the FDA’s vision of an integrated SDLC for C, C++, Java, and .NET with a software development management platform designed for medical device software development, preconfigured with processes and best practices described in the FDA guidelines and medical device industry standards.

Parasoft static analysis capabilities:

  1. Pattern-based static analysis
  2. Flow-based static analysis
  3. Metrics-based static analysis

In addition to static analysis, data flow analysis and code metrics, Parasoft’s integrated multilanguage solutions also facilitate code review, unit testing, regression testing, runtime error detection, manual testing, and SOA/web/cloud functional and load testing.

Parasoft has assisted many organizations developing medical device software to establish auditable quality processes for complete visibility into compliance efforts. For more information about Parasoft’s complete software development management platform for the medical device software development market, read the full whitepaper.

About Parasoft

Parasoft helps organizations continuously deliver quality software with its market-proven, integrated suite of automated software testing tools. Supporting the embedded, enterprise, and IoT markets, Parasoft’s technologies reduce the time, effort, and cost of delivering secure, reliable, and compliant software by integrating everything from deep code analysis and unit testing to web UI and API testing, plus service virtualization and complete code coverage, into the delivery pipeline. Bringing all this together, Parasoft’s award winning reporting and analytics dashboard delivers a centralized view of quality enabling organizations to deliver with confidence and succeed in today’s most strategic ecosystems and development initiatives — security, safety-critical, Agile, DevOps, and continuous testing.