Version 2.0 Release Notes
February 26th, 2025
P4SaMD v2.0.0 is the first release of the platform for Software as a Medical Device (SaMD), designed to guide organizations through the complex SaMD development process. It aims to ensure compliance with regulatory requirements like FDA (US) and MDR (EU) and simplify certification, building upon IEC 62304 and related standards.
This platform provides a comprehensive workflow for managing the Software Development Lifecycle (SDLC) for cloud-based applications, integrating various tools and automating key processes for device quality and compliance.
Comprehensive SDLC Guidance
Provides an overall support throughout the whole Software Development Lifecycle, through pre-set path from design, and approval to the implementation and release of the Software System. The whole SDLC is monitored by Key Performance Indicators (KPIs) for requirements, risks, tests, changes, and software items on the software system.
P4SaMD enables visualization and navigability through release versions (released, in-progress, and planned) with key details of each of them; it also offers quick access to the last worked on version for immediate resumption of work.
Furthermore, it provides insights and suggestions that guide you in the SDLC for meeting with lower effort the strict regulatory requirements
Automated Documentation and Reporting
Allows users to get and download version-specific reports and entity information, which are always up-to-date at the moment of download. Reports include Release Notes, Risk Reports, Test Reports (for unit, integration and system tests), Change Reports, SOUP Reports, S-BOM files, Changelogs for custom software components.
Traceability
P4SaMD provides end-to-end traceability by supporting links between requirements, software item design and implementation, verification, validation, risks, and changes. This real-time traceability matrix, that ensures also full traceability of changes via software system versions, addresses the compliance with standards for high quality software, such as IEC 62304.
Design and Development Control
Software System architecture design is supported through the definition of the hierarchy of Software Items (SWI) of the Software System, including all the descriptive information of the items and smart suggestions when information are missing. The user can classify the Software Items based on the safety classification (A,B,C) and can differentiate them by type (SOUP, AI-based components, ..). Every design change is tracked, thanks to a version log of their full history.
The Software Item implementation is guided via shortcuts to ready-to-use modules and software components to be included in the Software System. Automatic controls guarantee constant checks of the implementation versus the Software specifications, allowing early detection of anomalies. P4SaMD provides features for dependencies control (SOUP and S-BOM), approval and documentation.
Test & Verification
Supports automated control and verification of SWI implementation against the design, provides features for managing integration and system test and keeps the traceability to requirements; it also facilitates the SOUP design and formal verification.
Risk Management
Users are supported in risk identification, analysis and mitigation through the available risk framework which supports all the risk management stages for the reference standard maintaining the traceability to SWIs, Risk Control Measures and related changes if present. Customizable scale show the users the overall risk levels and the related residual value after mitigations.
Change Management
P4SaMD supports the change control through the change request visualization, analysis and lifecycle. This feature ensures full traceability of changes.
Configuration Management
P4SaMD relies on IDP configuration management strategies, including Public Variables management and Secret Variables management.
P4SaMD Product information
Integration and Security Enhancements
Supports integration with external Application Lifecycle Management (ALM) tools (initially Jira) to synchronize project data and collect information from different sources. Cybersecurity is addressed by Access Management, Data Security policies and Network and Infrastructure Security measures, following the latest international cybersecurity guidelines.
Compliance and Validation
P4SaMD is a validated tool, for more information please go to the FAQ section.
Released Software Item Components
| SWI | Version |
|---|---|
| P4SaMD Frontend | v1.0.1 |
| P4SaMD Backend | v1.0.0 |
| Pipelines Templates | v0.2.1 |