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Medical | IEC 62304 | FDA

Developing safe and effective medical devices requires a balance of effective requirements management, risk mitigation, and automation. Controlling risk in this environment is also a function of cost and time, which device manufacturers must consider in their efforts to compete successfully. To achieve all of these goals, many device manufacturers are transitioning to the IEC 62304 standard in the hope that it will both help mitigate risk and expedite their path to device approval.

Manually following the processes, activities, and tasks identified in this standard can consume significant time and energy contributing to overall increased cost to clearance. Most companies try to reuse or leverage external libraries and code that is “proven in use” to shorten their development time and reduce cost. However, this typical software of unknown pedigree (SOUP) must still be considered in the overall evaluation of the safety and effectiveness of the device. Developers need strategies and technologies to verify these components through requirements-based testing. Equally important is the delivery of verification evidence and traceability throughout the software development life cycle to meet the needs of the regulatory authorities and support audits of the development process.

LDRA provides a powerful, cost-effective and flexible tool suite for medical device software development

The LDRA tool suite is the most complete software verification and validation solution for the development of medical device software. These tools support the FDA and other medical device regulatory body guidelines from device development through device clearance and audit support.

LDRA provides significant advantages for developers of safety-critical medical devices:

  • Requirements Traceability. TBreq is the only requirements traceability solution that supports the tracing of requirements, development, and verification artifacts and activities throughout the entire software development life cycle. This bidirectional traceability ensures complete coverage and impact analysis through all phases of development, from a requirement through development to verification, and the production of evidence and documentation in a comprehensive requirements traceability matrix. TBreq inherently supports requirements-based testing, a fundamental technique to mitigate risk and determine the safety and effectiveness of a medical device.
  • Code Inspection. TBvision's static analysis capabilities help you quickly identify and eliminate latent defects in code and enforce coding standards compliance. With today’s medical devices becoming increasingly complex, mobile, and connected, it is extremely important to assess code quality efficiently. Manual inspection is no longer an option as it is both time-consuming and error-prone. Static analysis for medical devices has been recognised as an industry best practice for quickly and efficiently improving overall code quality.
  • Coding Standards Compliance. TBvision’s static analysis capabilities simplify the enforcement of coding standards across your organisation, improving the overall consistency and quality of the code. TBvision helps your team develop and enforce the coding standard that is right for you from in-house best practices and guidelines to industry coding standards or a combination of in-house and industry standards. Examples of supported standards include MISRA C, MISRA C++, CERT C, CERT C++, CERT Java, Netrino, and JSF++ AV.
  • Unit and System Testing. TBrun provides rigorous unit testing early in the development lifecycle as advocated by regulatory guidelines. TBrun automates the generation and execution of requirements-driven tests both on the host platform as well as the embedded target, and produces the necessary verification evidence for regulatory bodies. TBrun also supports regression testing, saving time and money when requirements or code change during the software development life cycle.
  • Automated Test Case Generation. The TBeXtreme module provides automated test case generation that saves test generation time in comparison to manual methods. This module helps improve code quality while alleviating the onerous nature and inherent inaccuracies prevalent in a manual unit testing process.
  • Structural Coverage Analysis. The LDRA tool suite lets your team meet the most rigorous structural coverage analysis requirements, including statement, branch/decision, procedure/function call, Modified Condition/Decision Coverage (MC/DC), and dynamic data flow. All of this can be shown and reported graphically, enhancing the process of producing verification evidence.
  • Tool Qualification. LDRA provides support for the qualification of its tool suite for both structural coverage analysis (SCA) as well as for programming rules checking (PRC). The LDRA Tool Qualification Support Packs (TQSPs) contain the test cases to demonstrate both the SCA and PRC capabilities of the tool suite itself. In addition, associated documentation for the development and verification of the product is provided, including plans, procedures, and expected results.
  • Secure Code. With the rise in networked medical devices, the FDA has established that security is a shared responsibility between medical device manufacturers and medical device user facilities. TBvision helps you ensure that deployed medical devices meet the highest security standards by assessing code against the CWE, CERT C, CERT C++, and CERT Java standards.
  • Complete Platform Support. The LDRA tool suite supports an extensive list of target platforms , providing a common test environment and processes for medical device product-line development, including those based on the latest processors and operating systems.

LDRA provides a powerful, cost-effective and flexible tool suite for medical device software development

The LDRA tool suite is the most complete software verification and validation solution for the development of medical device software. These tools support the FDA and other medical device regulatory body guidelines from device development through device clearance and audit support.

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What people say

A tool enforcing IEC 62304 mitigates risk and provides extra security and confidence that the software developed will meet requirements and be error free.

Esprit Lean