Quality Management

Documented, traceable, audit-ready.

In medical device development, quality depends on documented proof. Our embedded computing platforms are developed to medical standards and supplied with project-specific evidence — including EMC assessments (e.g. EN 60601-1-2 in the system context), structured test records, and transparent lifecycle data. 
Through our consulting, customization, and documentation services, we help you build and maintain a compliant design history file (DHF) with minimal effort.

IEC 60601-1 test reports available Lifecycle + EOL transparency Proven use in critical medical systems Audit-ready documentation sets

Standards alignment + compliance

Our boards are engineered for medical use and developed in line with EMC, safety and software standards (ISO 13485, IEC 62304, ISO 14971, IEC 81001-5-1). 
They are designed to operate fanless, robust and long-term available, with documentation structured for OEM audits and regulatory submissions.

Documentation + traceability 

We provide complete documentation packs tailored to your project, covering:

Hardware and BSP baselines
Verification and validation results
Risk management and change logs
Defined system interfaces

This ensures traceability across the full lifecycle and supports internal QA reviews and external audits.

Verification + integration testing evidence

Using reference set-ups and integration points, we support:

Hardware-software verification
System-level integration tests
Regression and risk-based testing

Our engineering teams also assist with system integration, BSP adaptation and validation support, reducing QA workload.

Life-cycle transparency + change control 

With long-term availability and proactive obsolescence management, we enable predictable planning:

Early lifecycle and EOL notifications
Documented, compatible replacement options
Structured change control and traceability

Ensuring reliable operation and regulatory compliance throughout the device lifecycle.

FAQ

Do you provide documentation suitable for regulatory submissions (e.g., Design History File)?

Yes, you receive structured, standards-compliant documentation suitable for inclusion in the DHF, technical documentation, or submission files for regulatory approval.

What standards does your documentation support?

Our documentation can support requirements from a range of standards, such as ISO 13485, IEC 62304, ISO 14971, IEC 60601-1-2, and customer-specific regulations.

When will I be informed about EOL?

We provide timely notifications, including recommended alternatives where possible.

Are manufacturing and test records included?

Yes, manufacturing and test data are included as part of the overall documentation package.

References / Projects

Short examples from critical care, diagnostic imaging or surgical robotics demonstrate field experience and stability. Project-specific dossiers are available on request.