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FDA and Medical Device Software Development

Parasoft Development Testing solutions for medical device software development helps organizations overcome the burdens associated with medical device software development. Our technology automates the application of policies and practices that help businesses comply with industry standards, guidelines, and requirements, such as the FDA's Quality System.

FDA General Principles of Software Validation, IEC 62304 and More

Parasoft Development Testing Platform 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.
Regulation and IEC 62304.

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 tracing back 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.

Process, Project and Task Management

Our process, project and task management capabilities reduce risk by helping organizations bridge the gap between business expectations and development processes. Parasoft improves software lifecycle management processes by giving you the tools to communicate, document and enforce development policies.
Teams can set reasonable goals for the scope and duration of each release, and as business needs evolve, managers can analyze various scenarios to determine the best course of action. Moreover, if a project ever seems to stray from deadline, budget, functionality, or quality/compliance expectations, management is alerted immediately.
As a result of Parasoft's task management and monitoring capabilities, everyone involved in the project—from management to development to QA—has instant insight into work completed, work in progress, and how much work remains.

Integrated Software Development

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

The complexity and diversity of the development infrastructure hinders the consistent and efficient production of quality software. Without a centralized infrastructure, aggregating critical, objective data points becomes overwhelming. Parasoft Development Testing Platform aggregates and correlates elements to provide continuity and to facilitate collaboration across the distributed infrastructure. It easily plugs into your existing development infrastructure and correlates all key artifacts from disparate systems, including:

  • Requirements management systems
  • Bug tracking systems
  • IDEs
  • Source code repositories
  • Build management and integration systems
  • Test management systems
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