07 — DEV

Secure Software Development

Secure by design. From the first line of code.

Supports Software Item implementation with ready-to-use modules and software components, while implementing Secure by Design principles by continuously scanning for vulnerabilities and managing software supply chain security per IEC 81001-5-1.

What It Does

Security and compliance built into the development toolchain.

Medical software is an increasingly targeted attack surface. A vulnerability in a device software component is not just a security incident, it's a patient safety event and a regulatory failure. IEC 81001-5-1 sets the standard for health software cybersecurity, but satisfying it requires far more than a security audit at release time.

P4SaMD's Secure Software Development capability embeds IEC 81001-5-1 requirements directly into the development workflow, maintaining an up-to-date Software Bill of Materials and continuously scanning dependencies for known CVEs.

Key Features

Secure Component Library

Pre-validated modules for regulated development

A curated library of software components pre-validated against IEC 81001-5-1 security requirements, reducing development time while guaranteeing that foundational components meet the standard from the first import.

SBOM Management

Continuous Software Bill of Materials

Automatically generates and maintains a Software Bill of Materials for every software item, enabling real-time tracking of all third-party dependencies and instant response when a new CVE affects your product.

Vulnerability Scanning

Automated CVE detection with risk impact assessment

Continuously scans dependencies and infrastructure for known vulnerabilities, assessing each finding against its compliance impact, distinguishing between a minor update and a finding requiring an immediate risk management response.

Secure Development Guardrails

Prevent vulnerable code from entering the build

Enforces security coding standards and blocks dependencies with known critical vulnerabilities from being introduced into the codebase, making the insecure path structurally unavailable during development.

Standards Addressed

Built to satisfy the standards that matter most to your auditors.

IEC 81001-5-1IEC 62304ISO 13485

Related Use Cases

See it in action.

For Pre-Market Startups & Scaleups

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