Requirements & Risk
Link product/software requirements with risks, mitigations and verification.
IEC 62304 · Requirements · Risk · Verification
Medical Device Software Assurance
Connect medical-device requirements, risk, reviews, tests, software quality and security controls across regulated product-development workflows.
LifecycleIEC 62304
RequirementsVisure
Software V&VParasoft
SecuritywolfSSL where applicable
Capabilities
Core Capabilities
Capabilities and terminology aligned to the current partner portfolio and target application.
Review & Approval
Use contributor/reviewer workflows and controlled baselines.
C/C++ Verification
Apply static analysis, unit testing and coverage to embedded medical software.
Java / .NET Quality
Use Jtest or dotTEST for software components built on those stacks.
Traceability & Reporting
Generate matrices and evidence from ALM and test data.
Connected-Device Security
Use embedded TLS/cryptography/secure boot where networked device architectures require them.
Standards & Compliance
Standards and Regulatory Context
Relevant standards, coding guidelines and assurance frameworks for the technology and its application areas.
IEC 62304
ISO 14971 workflow context
FDA 21 CFR Part 11 review context
CWE / secure coding context
Industries
Industry Applications
Industry connections are included where the technology addresses a defined engineering, verification or product-security requirement.
Integrations & Deployment
Toolchain and Deployment
Connect the technology with the existing engineering environment, lifecycle tools, CI/CD platform and target architecture.
ALM
Visure
Code quality
C/C++test, Jtest, dotTEST
Security
wolfSSL / wolfCrypt / wolfBoot