FDA and Medical Device Software Development

Parasoft Development Testing Platform (DTP) for medical device software development helps organizations achieve compliance with submitted and approved processes. Parasoft DTP also assists organizations to continuously improve software quality practices as documented by the General Principles of Software Validation.

Out-of-the-box Support for FDA, IEC 62304, More

Parasoft drives any policy or combination of policies your organization is required to follow. Our automated solution provides out-of-the-box support for common medical device regulations, including FDA General Principles of Software Validation and IEC 62304. Parasoft works with each organization to optimize the solution for the unique demands of medical device software requirements. This jumpstarts compliance and establishes the foundation for continuous improvement. Development teams are better equipped to meet management expectations while achieving unprecedented levels of productivity and application quality.

Integrated Defect Prevention, Validation and Verification

Parasoft’s development testing solutions for C/C++, Java, .NET, SOA, Web, and messaging protocols provide teams the industry’s broadest spectrum of integrated defect prevention and detection technologies. Parasoft provides out-of-the-box automation of validation practices identified in the FDA’s General Principles of Software Validation, including: This improves productivity by reducing defects prior to the QA phase—defects that become difficult and expensive to remediate the deeper they go into the development process. Our verification and validation technologies strengthen code, making it easier to evolve and reuse. Parasoft integrates development testing, functional testing, load testing, manual user acceptance testing, and service virtualization (which emulates the behavior of application or device components that you cannot or do not want to access during testing) into a seamless process.

Comprehensive Requirements Traceability

For traceability, requirements are correlated with automated and manual tests, source code, and development/testing tasks. The current level of verification for each requirement or task (including task pass/fail status and coverage) can be assessed at any time by back tracing to all associated tests. This correlation also enables change-based testing, which identifies exactly which tests are impacted by source code and requirement modifications. Teams know exactly which tests need to be rerun and which code needs to be re-reviewed.

In addition to tracking when the functionality for each requirement is implemented and tested, Parasoft also monitors compliance to non-functional requirements (e.g., coding standards, peer review, coverage, etc.) The system can be configured so that functionality is not considered “complete” unless it complies with the team’s quality expectations.

Continuous Compliance Process

Parasoft establishes a continuous compliance process that ensures compliance tasks begin early and are deployed across every stage of the SDLC per FDA recommendations. Our policy-driven approach guides development and testing guidelines toward actionable, measurable compliance tasks. An automated infrastructure runs in the background, orchestrating mandated processes (manual and automated), and continuously monitors policy compliance. Notifications are generated only when actions don’t align with policy expectations. In this way, SDLC tasks are driven to a predictable outcome according to defined industry standards or management’s expectations. Management gets real-time visibility into how the software is being developed and developers gain immediate objective that helps them satisfy compliance policies. This reduces the need to redo work already completed and committed, which enables the team to focus on delivering the expected functionality on time and on budget.

Seamless Integration

Parasoft seamlessly integrates with any development environment and any development language to provide meaningful, actionable data from disparate system components, including:
  • Requirements management systems
  • Bug tracking systems
  • IDEs
  • Source code repositories
  • Build management and integration systems
  • Test management systems
Parasoft plugs directly into common embedded environments, including Eclipse, Wind River Workbench, ARM RVDS, QNX Momentics, Texas Instruments CCS, and Microsoft Visual Studio. Enhanced support is also available for Green Hills MULTI, ARM ADS, IAR Embedded Workbench, Keil RealView, Microsoft eMbedded Visual C++ and Visual Studio 6, .NET Compact Framework, and Wind River Tornado.