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FDA and Medical Device Software Development
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Medical device software development is rife with business process and technological challenges associated with
regulatory compliance. Many organizations lack process automation, which ensures that developers adhere to
the defined and approved development guidelines, which opens the door to significant business risk as well as
quality, security and reliability defects.
Parasoft solutions enable a policy-driven development approach that mitigates medical device software
development issues. Policy-driven software development bridges the gap between business goals and
development processes, which provides organizations with the ability to accurately and objectively
measure adherence to defined processes and application quality. The result is lower development
costs and reduced risk.
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The Parasoft Concerto software development management platform 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 Regulation and IEC 62304.
Concerto seamlessly integrates project and task management into any development environment and toolset. It is part of a
broader ground-breaking suite rounded out by Parasoft Test's Automated Defect Prevention and end-to-end software
verification and validation technologies—as well as Parasoft Virtualize's dev/test environment management.
With this solution, you can uniformly apply the least burdensome practices to mitigate the safety risks associated with your applications.
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Parasoft Concerto 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.
Learn more about static analysis for FDA/medical software
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Parasoft Test gives teams the industry's broadest spectrum of integrated defect prevention and detection technologies for
C,
C++,
Java, and
.NET,
Web,
SOA, and
multiple messaging protocols.
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.
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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.
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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.
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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 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.
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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 Concerto 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 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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