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Merge pull request #38 from mia-care/release-notes-2.2
Add release notes
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‎.cspell.json‎

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"version": "0.2",
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"language": "en",
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‎docs/p4samd/img/MC-p4samd-ai-powered-evaluation.png‎

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‎docs/p4samd/img/MC-p4samd-vulnerability-v2.2.png‎

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‎docs/p4samd/release-notes/v2.0.md‎

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---
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id: v2.0
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title: Version 2.0 Release Notes
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sidebar_label: v2.0
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---
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_February 26th, 2025_
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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.
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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.
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## Comprehensive SDLC Guidance
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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.
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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.
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Furthermore, it provides insights and suggestions that guide you in the SDLC for meeting with lower effort the strict regulatory requirements
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## Automated Documentation and Reporting
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Allows users to get and download version-specific reports and entity information, which are always up-to-date at the moment of download.
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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.
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## Traceability
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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.
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## Design and Development Control
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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.
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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.
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## Test & Verification
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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.
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## Risk Management
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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.
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## Change Management
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P4SaMD supports the change control through the change request visualization, analysis and lifecycle. This feature ensures full traceability of changes.
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## Configuration Management
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P4SaMD relies on IDP configuration management strategies, including Public Variables management and Secret Variables management.
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## P4SaMD Product information
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### Integration and Security Enhancements
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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.
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### Compliance and Validation
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P4SaMD is a validated tool, for more information please go to the [FAQ section](../faq.md).
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## Released Software Item Components
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| SWI | Version |
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| ------------------- | ------- |
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| P4SaMD Frontend | v1.0.1 |
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| P4SaMD Backend | v1.0.0 |
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| Pipelines Templates | v0.2.1 |

‎docs/p4samd/release-notes/v2.1.md‎

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---
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id: v2.1
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title: Version 2.1 Release Notes
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sidebar_label: v2.1
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---
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_May 28th, 2025_
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## AI-powered assessment of Design Input
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P4SaMD introduces AI-powered features to enhance quality and accelerate the development process: the first features aim to to improve the quality of design inputs and testing:
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- **AI-powered Quality Evaluation**: Provides AI-based evaluation and insights about requirement and test quality and suggests improvements and identifies missing or inconsistent mandatory data. The feature reduces the team effort and improving the overall quality of specifications. The context of the AI model is set for referencing the compliance with specific criteria of reference standards, that can be tuned with respect to the target industry (e.g., healthcare with IEC 62304).
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- **Test Coverage estimation**: for each software requirement, the AI-powered tool calculates an estimation of the Test Coverage given by the verification tasks or tests that the user has associated to the requirement. The percentages of Test Coverage support the user in reaching the verification of the complete software system, ensuring the good development of the product.
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![AI-powered Quality Evaluation of Requirements](../img/MC-p4samd-ai-powered-evaluation.png)
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## Enhanced Software Item Management
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### AI-based SWI framework
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The user is supported by a structured framework to address all the newest regulatory requirements regarding the dealing with AI-based models and agent. This simplifies the software design, decreasing the cognitive load needed to include AI model while manufacturing a product (e.g., AI Act, AI-specific IMDRF guidelines and FDA directives are addressed by the tool).
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### Improved Traceability
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The system now offers a robust mechanism for establishing, managing, and documenting links between Software Items (SWIs) and related entities such as Requirements, Risks, Tests, and Changes. This linking can be performed directly from the respective entity sections, ensuring comprehensive traceability.
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### Centralized Documentation References
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A centralized section is now available for all the team members, from developers to QA engineers, presenting a curated list of documentation links relevant to your SaMD development. They can include regulatory references, internal Standard Operating Procedures (SOP), guidelines and other documents; customizable with tags/labels for classification and with search functionality for easy access.
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### Graphical Visualization of Software Item Design
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Software Items can now be visualized graphically, showing their hierarchical relationships (parent and children) up to the second level. This view provides key status information and includes a legend for clarity.
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## Released Software Item Components
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| SWI | Version |
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| ------------------- | ------- |
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| P4SaMD Frontend | v1.3.0 |
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| P4SaMD Backend | v1.2.1 |
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| Pipelines Templates | v0.2.2 |
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| P4SaMD AI Service | v1.2.0 |
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:::info
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### How to get the new version
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Please [contact Mia-Care](mailto:[email protected]?subject=P4SaMD%20update%20v2.1&body=Hello%20Mia-Care%20Team,%0A%0AI%20am%20interested%20in%20upgrading%20P4SaMD%20to%20v2.2%20...) to get an upgrade of P4SaMD to this brand new released version.
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:::

‎docs/p4samd/release-notes/v2.2.md‎

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---
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id: v2.2
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title: Version 2.2 Release Notes
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sidebar_label: v2.2
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---
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_July 16th, 2025_
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## Vulnerability Management
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P4SaMD now allows the real-time detection, tracking, and reporting of vulnerabilities in the system version under development. Following the ISO 81001-5-1, the detected vulnerabilities of the implemented software can be resolved directly in the source code or accepted, reporting a rationale to justify the action.
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![Vulnerability Management table](../img/MC-p4samd-vulnerability-v2.2.png)
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## Seamless authentication with Single-Sign On
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Integrating the Single Sign-On (SSO), the tool offers a seamless login with your Console credentials to access the Software System dashboard.
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## New Insights & Suggestions
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New warnings and informational insights for SWI management, including:
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- warning of _Undocumented SWI classification_ that guides the user to meet the regulatory requirement of justification for SWI re-classification during the Software System decomposition;
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- inform and highlights the possible mis-classification due to incoherent decomposed SWI class;
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- tool also warns the users when the design is missing for an implemented SWI;
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- information guidance for setting up important SWI data, in preparation for proper P4SaMD functioning. This rule, referring to _missing RepositoryID_, is now applied only for second and third level SWIs, not on Project-level SWIs.
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## Software Item Management improvements
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- **Customizable Software System Settings**: Users can now tailor their system view by including or excluding specific Console Projects, improving clarity and documentation relevance
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- **Enhanced SWI Management**: New properties enable better reusability of Software Items (SWI) and ensure comprehensive tracking of approvals and documentation.
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## Minor improvements & Bugs
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### Dashboard
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Graphical improvements of the insights and suggestions counts are introduced, including color coded chips and correct alignments of elements.
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### Test section
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For each test, the details now show the entire description to be performed and the current assignee of the test execution.
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## Released Software Item Components
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| SWI | Version |
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| ------------------- | ------- |
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| P4SaMD Frontend | v1.3.0 |
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| P4SaMD Backend | v1.4.0 |
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| Pipelines Templates | v0.2.2 |
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| P4SaMD AI Service | v1.2.0 |
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:::info
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### How to get the new version
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Please [contact Mia-Care](mailto:[email protected]?subject=P4SaMD%20update%20v2.2&body=Hello%20Mia-Care%20Team,%0A%0AI%20am%20interested%20in%20upgrading%20P4SaMD%20to%20v2.2%20...) to get an upgrade of P4SaMD to this brand new released version.
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:::

‎docs/p4samd/release_notes.md‎

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---
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id: release_notes
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title: Release Notes
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sidebar_label: Release Notes
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---
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| Release Version | Release notes |
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| --------------- | ----------------------------------------------- |
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| v2.2 | [Read the release notes](release-notes/v2.2.md) |
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| v2.1 | [Read the release notes](release-notes/v2.1.md) |
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| v2.0 | [Read the release notes](release-notes/v2.0.md) |

‎docusaurus.config.js‎

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},
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navbar: {
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hideOnScroll: false,
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title: "Mia-Care Docs",
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title: "Mia-Care P4SaMD",
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logo: {
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alt: "Mia-Care logo",
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src: "img/logo.png",
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},
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items: [
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{
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label: "Products",
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label: "Product",
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position: "left",
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activeBaseRegex: "(docs|docs/\\d.x)/(development_suite|marketplace|libraries|tools|runtime_suite|microfrontend-composer|fast_data|dev_portal)",
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type: "dropdown",
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items: [{
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type: 'doc',
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docId: "p4samd/overview",
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label: "P4SaMD",
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activeBaseRegex: "(docs|docs/\\d.x)/p4samd"
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}
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]
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type: "doc",
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docId: "p4samd/overview",
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},
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{
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label: "Release Notes",
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position: "left",
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type: "doc",
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docId: "p4samd/release_notes",
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},
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{
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href: "https://mia-care.io/competence-center/video/mia-care-product-demo-platform-for-software-as-a-medical-device/",

‎versioned_docs/version-2.0.x/p4samd/release-notes/v2.0.md‎

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---
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id: v2.0
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title: Version 2.0 Release Notes
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sidebar_label: v2.0
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---
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_February 26th, 2025_
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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.
10+
11+
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.
12+
13+
## Comprehensive SDLC Guidance
14+
15+
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.
16+
17+
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.
18+
19+
Furthermore, it provides insights and suggestions that guide you in the SDLC for meeting with lower effort the strict regulatory requirements
20+
21+
## Automated Documentation and Reporting
22+
23+
Allows users to get and download version-specific reports and entity information, which are always up-to-date at the moment of download.
24+
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.
25+
26+
## Traceability
27+
28+
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.
29+
30+
## Design and Development Control
31+
32+
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.
33+
34+
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.
35+
36+
## Test & Verification
37+
38+
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.
39+
40+
## Risk Management
41+
42+
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.
43+
44+
## Change Management
45+
46+
P4SaMD supports the change control through the change request visualization, analysis and lifecycle. This feature ensures full traceability of changes.
47+
48+
## Configuration Management
49+
50+
P4SaMD relies on IDP configuration management strategies, including Public Variables management and Secret Variables management.
51+
52+
## P4SaMD Product information
53+
54+
### Integration and Security Enhancements
55+
56+
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.
57+
58+
### Compliance and Validation
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P4SaMD is a validated tool, for more information please go to the [FAQ section](../faq.md).
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## Released Software Item Components
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64+
| SWI | Version |
65+
| ------------------- | ------- |
66+
| P4SaMD Frontend | v1.0.1 |
67+
| P4SaMD Backend | v1.0.0 |
68+
| Pipelines Templates | v0.2.1 |

‎versioned_docs/version-2.0.x/p4samd/release_notes.md‎

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---
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id: release_notes
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title: Release Notes
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sidebar_label: Release Notes
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---
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| Release Version | Release notes |
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| --------------- | ----------------------------------------------- |
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| v2.0 | [Read the release notes](release-notes/v2.0.md) |

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