Release Notes — Current (v3.x)
P4SaMD v3.0
Release date: 26 May 2026
Version 3.0 is a complete re-architecture of P4SaMD. This release marks the beginning of the v3 product line. It delivers a standalone platform that operates independently of any third-party software infrastructure.
What's New
Standalone Platform
P4SaMD v3 runs as an independent product with its own dedicated user interface. It no longer requires Mia-Platform Console or any other external platform to be deployed or in use by your organization.
Federated Authentication
Authentication in v3 uses a federated OIDC identity provider bundled with the P4SaMD installation. The two-token authentication model — login token plus tenant-scoped token — provides a secure, IdP-independent session management system. Switching to a different identity provider in the future requires only a configuration update.
Multi-Tenant Architecture
A single P4SaMD installation now serves multiple independent organizations simultaneously. Each organization has complete data isolation from others on the same installation. Users can belong to multiple organizations and switch between them without logging out.
Native Work-Item Management
Requirements, risks, tests, and change requests are now managed natively inside P4SaMD. An external ALM tool (such as Jira) is no longer required to start using the platform. External ALM integrations remain available as optional bidirectional synchronization features.
Multiple Projects per Organization
Organizations can now manage multiple medical device software projects in a single P4SaMD instance. Each project has its own team, configuration, compliance context, and version history.
Self-Service Configuration
Organizations and projects can be configured autonomously through the platform interface, without requiring Mia-Care to perform changes on your behalf. This includes integration setup, workflow configuration, and organizational settings.
Brownfield Import
The Brownfield Import wizard enables onboarding of existing software projects. A six-step guided workflow collects project context, technical assets, and existing documentation, then triggers an automated compliance gap analysis and generates a prioritized remediation plan.
Requirements Management (v3 Architecture)
Requirements are now managed as native platform entities with a hierarchical tree structure, lifecycle statuses (Draft → In Review → Approved → Verified), bidirectional traceability, and import/export capabilities. No external ALM synchronization is required.
Version Management
Workspace versions provide IEC 62304-aligned configuration management. Draft versions support active development; released versions are permanently locked as compliance records.
Upgrading from v2
P4SaMD v3 is a new platform. There is no direct in-place migration path from v2. Organizations moving from v2 are recommended to use the Brownfield Import feature to onboard their existing projects into the v3 platform. Contact Mia-Care for migration support.
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
Full risk management capabilities including hazard analysis, risk assessment worksheets, residual risk evaluation, and ISO 14971-compliant risk management reports. Bidirectional traceability between risks, requirements, and mitigations.
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.
Smart Insight AI Advisor
Context-aware AI assistant that provides intelligent suggestions for requirement writing, gap analysis recommendations, and compliance best practices. Trained on medical device regulatory frameworks and software engineering standards.
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.
Each minor release will include detailed documentation of new capabilities as they become available. Subscribe to release notifications or contact Mia-Care for roadmap updates and feature access Release notes for each subsequent minor version will document new capabilities as they become available.