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FDA and Medical Device Software Development
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Parasoft Concerto is a Software Development Management platform that ensures that medical device software can be produced consistently and efficiently with freedom from unacceptable risks. Parasoft Concerto for Medical Device Software Development is a pre-configured system with processes and best practices that assists organizations to meet FDA guidelines and medical device industry standards for software development.
Our ground-breaking technology integrates
project and task management
with Automated Defect Prevention and end-to-end software verification and validation.
This integrated platform is policy-driven,
allowing your organization to uniformly apply the least burdensome practices to mitigate the safety risks associated with your applications.
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Parasoft Concerto can be applied to drive any policy or combination of policies that your organization is required to follow.
It is preconfigured with templates for common regulations related to medical device software development, including FDA General Principles of Software Validation, ANSI 62304, IEC & SIL
Parasoft works with each organization to optimize the templates for the organization's unique demands. This jumpstarts compliance and establishes the foundation for continuous improvement. The result: Compliance to management expectations while driving unprecedented levels of productivity and application quality.
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Parasoft Concerto's Test Center gives teams the industry's broadest spectrum of integrated defect prevention and detection technologies in an integrated solution for
C,
C++,
Java, and
.NET,
Web,
SOA, and
multiple messaging protocols).
Parasoft provides out-of-the-box automation of the validation practices named in the FDA's General Principles of Software Validation, including:
- Static code analysis - coding standards, data flow, metrics.
- Dynamic analysis - unit/component testing, integration testing, functional testing, memory error detection, continuous regression testing.
- Coverage analysis - Multiple coverage metrics
- Peer review (and document review) process automation
This improves productivity by reducing the amount and difficulty of downstream debugging—and by making code easier to
evolve and reuse. Parasoft Concerto also integrates functional testing, load testing, manual user acceptance testing,
and application behavior virtualization (emulates the behavior of application or device components that you cannot or
do not want to access during testing) into a seamless process.
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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.
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Parasoft Concerto reduces the risk involved in managing software life cycle processes. Our process, project and task management capabilities help teams set reasonable goals for the scope and duration of each release. As business needs evolve, managers can analyze various scenarios to determine the best course of action. And if it ever seems that the project is straying from deadline, budget, functionality, or quality/compliance expectations, management is alerted immediately.
Through this task management and monitoring, everyone involved in the project—from management to development to QA—has instant insight into what has been completed, what's in progress, what should be done next, and how much work remains.
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Parasoft establishes a continuous compliance process that ensures compliance tasks begin early and are deployed across every stage of the SDLC, as recommended by the FDA. Our policy-driven approach guides the organization to convert compliance guidelines for development and testing into actionable, measurable work tasks. An automated infrastructure runs in the background, orchestrating mandated processes (manual and automated), and continuously monitoring policy compliance. Notifications are generated only when actions don't align with policy expectations.
While management gets real-time visibility into how the software is being developed, developers gain immediate, objective feedback on whether their work is satisfying compliance policies. This reduces the need for rework, enabling the team to focus on delivering the expected functionality on time and on budget.
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One of the major hurdles in producing quality software consistently and efficiently is the complexity and diversity of the development infrastructure. This lack of centralization makes aggregating critical, objective data points seem like an overwhelming endeavor.
Parasoft Concerto aggregates and correlates these elements, bridging gaps to provide continuity and facilitate collaboration across the distributed infrastructure. It easily plugs into each site's existing development infrastructure and correlates all key
artifacts, from tests, to requirements, to code, to builds, to project tasks. Concerto connects:
- Requirements management systems
- Bug tracking systems
- IDEs
- Source code repositories
- Build management and integration systems
- Test management systems
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