Product Roadmap
P4SaMD v3 is an evolving platform. The features below are actively in development and will roll out in upcoming minor releases throughout 2026 and beyond.
Risk Management
ISO 14971-compliant risk management with hazard identification, 5×5 severity/probability risk matrix, automatic risk level computation (Unacceptable / ALARP / Acceptable), control measures, residual risk tracking, and a full status lifecycle. Bidirectional traceability between risks, requirements, and verification evidence. CSV import and export included.
Whisper AI Assistant
Context-aware in-platform AI assistant (Whisper), available in beta from v3.2. Provides AI-detected compliance suggestions against the active version and a conversational chat that can read project data and propose changes for you to confirm. Grounded in medical device regulatory frameworks and software engineering standards. Future iterations will expand coverage and proactive guidance.
Verification & Validation Execution
Execute test plans directly in P4SaMD with test case assignment, execution tracking, evidence attachment, and pass/fail reporting. IEC 62304-aligned V&V documentation generation with full traceability to requirements and design.
SDLC Workflow Orchestrator
Automated workflow engine that coordinates development activities across the software lifecycle. CI/CD pipeline integration for automated test triggering, build verification, and compliance gate enforcement.
Documentation Engine
Auto-generated compliance documentation including Software Development Plans, Risk Management Reports, Verification Reports, and Technical Files. Template-based output with PDF export and regulatory submission packaging.
System Design & Architecture
System architecture modeling with component diagrams, interface specifications, and design rationale capture. Automated generation of Software Architecture Documents and Detailed Design Specifications aligned to IEC 62304 requirements.
BOM Management & SBOM
Bill of Materials management for software components, dependencies, and SOUP items. Automated SBOM generation in SPDX and CycloneDX formats. License compliance tracking and vulnerability correlation.
Post-Market Surveillance
Post-market monitoring dashboard with adverse event tracking, complaint management, field action coordination, and trend analysis. Integration capabilities with vigilance reporting systems and regulatory authority portals.
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