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Mia-Care P4SaMD
07 — DEV

Secure Software Development

Secure by design. From the first line of code.

Supports Software Item implementation with full design control at every stage — from specification to code — while enforcing continuous implementation verification and managing the full software supply chain through dependency control and vulnerability management per IEC 81001-5-1.

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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 security and compliance controls directly into the development workflow: keeping design files aligned with implementation at every stage, detecting anomalies between software specifications and actual code early, and managing the full dependency and vulnerability lifecycle — from detection to approval and documentation.

In Action
Dashboard
Security
SBOM
Vuln. Scan
Guardrails
Component Lib.
Mia-Care Dev›App Cardio-Monitor›SBOM
Total Deps
47
CVE Found
2
Outdated
5
Up-to-date
40
Package
Version
License
Status
openssl
3.1.4
Apache-2.0
CVE Found
lodash
4.17.21
MIT
Up-to-date
express
4.18.2
MIT
Up-to-date
axios
1.6.0
MIT
Outdated
log4j-core
2.14.1
Apache-2.0
CVE Found
jsonwebtoken
9.0.0
MIT
Up-to-date

Software Bill of Materials — every third-party dependency tracked, versioned, and continuously checked against the NVD, GitHub Advisory, and OSV databases. One new CVE disclosure triggers an immediate alert across every affected project.

Key Features
Implementation Verification

Continuous checks of implementation against software specifications

Automatic controls guarantee constant verification of implementation against software specifications at every level — design files, code, and test artifacts — enabling early detection of anomalies before they propagate into the compliance record.

SBOM Management

Dependency detection, approval, and documentation

Plug-and-play dependency detection automatically generates and maintains the Software Bill of Materials for every software item. Every dependency is tracked, approved, and documented — giving teams full visibility into their software supply chain with minimal setup.

Vulnerability Management

Automated CVE detection with risk impact assessment

Covers the full vulnerability lifecycle: automated detection, risk-based mitigation planning, approval workflow, and documentation — distinguishing between a minor dependency update and a finding requiring an immediate risk management response under IEC 81001-5-1.

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

SaMD Greenfield Development

Building a SaMD from scratch means two simultaneous challenges: writing the software and satisfying the regulator. P4SaMD makes them the same phase.

Read Use CaseFor AI-Native SaMD Enterprise

Building High-Risk AI Software (CDSS)

AI-based clinical software evolves dynamically, but traditional compliance models assume requirements are static. P4SaMD decouples your engineering velocity from regulatory rigidity.

Read Use CaseFor MedTech Giants & Life Sciences Enterprises

Legacy Regulated Software Remediation

Many organizations hold valuable legacy software trapped by regulatory debt. P4SaMD provides a structured path to certification without rebuilding from scratch.

Read Use Case
Pricing

Find the right plan for your team.

From your first SaMD to enterprise-scale multi-product compliance — P4SaMD grows with you.

StandardSmall teams
ProfessionalGrowing teams
UnlimitedEnterprise
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compliant software faster?

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