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Software Verification Engineering for medical devices

For systems where failure is not an option.

Bitwave is a medical device software and firmware verification team based in Uruguay. We support the full verification lifecycle — from requirements to test protocols and security analysis — and help teams ship evidence-ready, FDA-aligned documentation under IEC 62304.

IEC 62304ISO 14971STRIDE
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Verification & cybersecurity — end to end

From unit testing and verification evidence to cybersecurity threat modeling, built for medical device teams.

Verification Planning & Traceability

From requirements to evidence, no gaps in traceability.

  • Requirements definition & review
  • Verification protocol writing
  • Traceability matrix (requirements ↔ tests ↔ risk)

Firmware & Software Testing

Formal testing, bugs found and closed — with reports that hold up under audit.

  • Formal testing of firmware and software
  • Bug identification and tracking
  • Verification reports

Cybersecurity Threat Modeling & Analysis

Threat modeling for connected devices, no fluff.

  • STRIDE and security architecture
  • BLE and mobile/API security
  • OWASP MASVS & IoT Top 10

Firmware Development Support & Design Verification

Hands-on support for your firmware team — we can commit code, not just review it.

  • Firmware development support (C/C++), working inside your codebase
  • Design verification against requirements
  • Architecture & testability review

Consulting & Ongoing Support

Need help for a sprint or capacity for the long run? Either works.

  • Code reviews and verification strategy
  • Testing tooling setup and best practices

Focused exclusively on medical device verification & cybersecurity

We work with medtech teams verifying and securing software-driven medical devices, from unit testing to cybersecurity analysis, aligned with the standards regulators expect.

Bench setup verifying a connected medical device against oscilloscope and code-level test output

IEC 62304 · ISO 14971 · ISO 13485

Verification Planning & Software Lifecycle

End-to-end verification for embedded firmware and medical device software, under IEC 62304 and ISO 14971. Requirements, protocol, testing, bug, closure — every step traceable.

  • Requirements definition, review, and traceability matrix
  • Verification protocol writing and formal test execution
  • Bug identification, reporting, and tracking through closure
  • Verification reports and change impact summaries
Learn more→
STRIDE threat model diagram mapping a connected medical device across trust boundaries

STRIDE · OWASP MASVS · FDA Cybersecurity

Medical Device Cybersecurity

Threat modeling and security architecture for connected medical devices (IoT/SaMD). Attack surface, BLE, and what regulators expect to see.

  • STRIDE threat modeling and security architecture review
  • BLE security: pairing, encryption, command authorization
  • Mobile app & API security (OWASP MASVS, IoT Top 10)
  • Traceable security documentation: requirements, controls, residual risk
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Embedded firmware development bench with PCB, code editor, and signal generator

Wearables · Implantables · IoT

Embedded Firmware Development Support & Testing

Hands-on firmware support for wearable, implantable, and connected medical devices — we can commit code directly when your team needs it, alongside unit testing and verification against requirements.

  • Firmware development support (C/C++), embedded in your team
  • Design verification against requirements
  • Unit testing with hardware abstraction & mocking
  • Fault handling, recovery paths, and testability review
Learn more→

Verification you can rely on

Bitwave is a medical device software and firmware verification team based in Uruguay. We support the full verification lifecycle — from requirements to test protocols and security analysis — and help teams ship evidence-ready, FDA-aligned documentation under IEC 62304.

How we work

We plug into your development process from day one: testability review, hardware abstraction, and a continuous regression mindset.

  • Early testability review
  • Hardware abstraction & mocks
  • Evidence packaged for audits

What you get

Deliverables that look like a verification organization, not ad-hoc testing.

  • Requirement-based test cases
  • Unit test suites and coverage reports
  • Verification notes and impact summaries

Capabilities

Embedded verification and cybersecurity analysis under one roof.

  • C/C++ unit testing & mocking
  • VectorCAST for critical environments
  • IEC 62304 contexts

Team model

We scale by assembling the right expertise for each engagement.

  • Core verification & security engineers
  • On-demand compliance support
  • Flexible staffing for any scope

Contact us

Tell us how we can help and we'll get back to you.