PLATFORM 4 SOFTWARE AS A MEDICAL DEVICE
AI-Powered SDLC Management for Compliant Software
P4SaMD is specifically designed and validated to support organizations in the complex process of developing Software as a Medical Device (SaMD), integrating AI-powered features to enhance software development lifecycle (SDLC) quality.
P4SaMD bridges the gap between cutting-edge software development practices and stringent regulatory requirements, ensuring teams can deliver high-quality, compliant products efficiently.
3x
Faster
time-to-market
50%
Average
cost savings
80%
Risk
reduction
100%
Compliance
GUIDED SDLC
Reduce cognitive load through a guided, IEC 62304-compliant DevX that simplifies adherence to best practices for Software as a Medical Device (SaMD) development. It provides overall support for software development processes, including AI-driven assistance providing smart suggestions on Design Input quality enhancement.
TRACEABILITY
Support end-to-end traceability from requirements to tests, passing through design, implementation and risk management artifacts.
DESIGN CONTROL
Convert requirements into software design components with structured system architecture support—including AI-based elements—ensuring full control and documentation at every stage.
PRODUCT DEVELOPMENT
Leverage built-in implementation controls aligned with the software design to automate critical processes, minimizing delays and bottlenecks. Simplify compliance with SaMD development standards and your Quality Management System (QMS), including configuration item management.
Design SaMD digital architectures, maintain the full governance of project features and follow the guidelines to comply with certifications.
- Compliant by design development environment
- Modular software components easy‑to‑certify
- Dev Experience, DevOps, and Agile methodologies
- Benefit from lean governance and secure QMS
AUTOMATED DOCUMENTATION
Automate the creation of key documentation to simplify compliance, significantly reducing manual effort while ensuring audit-ready evidence.
TEST & VERIFICATION
A comprehensive testing across the SDLC to ensure quality and validate acceptance criteria, with guided SOUP identification, formal verification, and automated evidence generation.
REQUIREMENTS MANAGEMENT
Thorough definition and classification of functional and non-functional requirements, with tailored insights and suggestions based on their type.
RISK MANAGEMENT
Enable a structured, iterative approach to managing risks related to software functionality, security, external system integration, and user interactions—helping prevent recalls and regulatory issues
P4SaMD product is validated according to GAMP5 Guidelines
ENABLING DIGITIZATION FOR THE BEST COMPANIES
