For FDA and medical device development, Parasoft’s core static analysis capability
is preconfigured with templates for common regulations related to medical device software development, including FDA General Principles of Software Validation, IEC 62304, IEC & SIL. This directly addresses the FDA’s recommendation to integrate static code analysis into the medical device software development process to detect problems before release.
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.
The FDA recommends not only that testing involve a mixture of test and analysis methods applied throughout the SDLC, but also that a broad set of software life cycle management and risk management activities be integrated across the process to ensure the delivery of safe and reliable software.
Parasoft addresses both of these expectations with Parasoft Concerto for Medical Device Software Development. This integrated system extends Parasoft’s static analysis capabilities—providing a pre-configured system with processes and best practices that help organizations produce medical device software consistently and efficiently, with freedom from unacceptable risks.
The complete ALM solution integrates project & task management with Automated Defect Prevention and end-to-end QA testing. It drives SDLC tasks to a predictable outcome according to defined industry standards or management’s expectations. This gives organizations the comprehensive process visibility & control needed to effectively satisfy quality and compliance requirements.