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IEC 62304ISO 1497121 CFR Part 820IEC 62366IEC 62443

Medical Device Software Built to Clear

IEC 62304-compliant engineering across the full software development lifecycle — from architecture and embedded systems through cloud integration, V&V, and audit-ready Design History File assembly.

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What We Deliver

Engineering Across the Full IEC 62304 Lifecycle

From SRS through DHF — every phase staffed with engineers who have shipped Class A, B, and C devices under regulatory scrutiny.

Architecture

Software Architecture & Design

We design software architectures that satisfy IEC 62304 Class A, B, and C requirements from the first commit — requirements traceability, modular unit-of-implementation boundaries, and interface specifications built in before a line of production code is written.

  • Software Requirements Specification (SRS) development
  • Architecture design with bidirectional traceability matrix
  • Interface control documents and API specifications
  • SOUP (software of unknown provenance) evaluation and documentation
Development

Embedded & Cloud Development

Production-grade engineering across the platforms medical devices actually run on — embedded C/C++ for real-time systems, Python and cloud-native services for connected health platforms, and mobile applications with platform-specific regulatory considerations.

  • Embedded C/C++ for real-time and safety-critical device software
  • Cloud-native microservices for connected health data platforms
  • Mobile application development (iOS/Android) for companion apps
  • Legacy system modernization with maintained regulatory traceability
V&V

Verification & Validation

V&V executed against the requirements you specified at the start — not reverse-engineered from the code you shipped. Every test case traces to a requirement; every requirement traces to a risk control in the ISO 14971 risk file.

  • Unit, integration, and system-level test execution
  • IEC 62366 usability engineering and summative evaluation
  • Cybersecurity testing aligned to IEC 62443
  • Independent V&V review and anomaly resolution
DHF

Design History File Assembly

The DHF is the regulatory record of everything your device went through to get cleared. We build it as a living artifact throughout development — not a last-minute documentation sprint before your 510(k) submission.

  • DHF structure aligned to 21 CFR Part 820 and ISO 13485
  • Continuous documentation throughout the SDLC — not retrofitted
  • Software problem report and change control records
  • Audit-ready package for FDA review or notified body assessment

IEC 62304 Classification

We Cover All Three Software Classes

Software class determines the rigor of the lifecycle process required. We staff and execute appropriately for Class A through C — no scope limitations.

Software Class
Risk Level
Examples
Class A

Basic maintenance process, anomaly resolution

Non-serious injury
Administrative software, non-life-sustaining apps
Class B

Full SDLC, V&V, problem resolution

Non-serious injury possible
Diagnostic aids, monitoring software
Class C

All Class B + detailed architecture, unit tests

Death or serious injury
Life-support, implantable device controllers

Our Process

From Concept to Cleared.

Five disciplined phases — every regulatory artifact built at the right moment, never retrofitted at the end.

  1. 01

    Classify

    Device & Software Classification

    IEC 62304 software class determination (A, B, or C), predicate device analysis, and regulatory pathway selection based on intended use and risk profile.

  2. 02

    Specify

    Requirements & Architecture

    Software Requirements Specification, system architecture, interface design, and traceability matrix — the complete technical foundation before any code is written.

  3. 03

    Build

    Compliant SDLC Execution

    Agile sprints with IEC 62304-gated milestones — unit implementation, peer-reviewed code, unit tests, and hazard-linked change control at every merge.

  4. 04

    Verify

    V&V & Usability Engineering

    System-level testing against every SRS requirement, IEC 62366 summative usability evaluation, and cybersecurity penetration testing.

  5. 05

    Submit

    DHF Assembly & Submission

    Audit-ready Design History File, 510(k) software documentation package, and post-market surveillance protocol — ready for FDA review.

Ready to Build Medical Device Software That Survives FDA Review?

Tell us your device class, development stage, and target market. We'll map the right IEC 62304 process structure and staff the team that gets you to clearance.

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