Quality assurance & testing services for medical software

Ensure your medical software is safe and secure by design, audit-ready, and built to the highest quality standards. As your critical supplier, we deliver solutions with QA and testing services built into every stage of the development, aligned with IEC 62304 and ISO 14971.

Why do medical device companies work with us?

MedTech companies work with us when quality assurance needs to be built into the development process from the start, providing traceability, audit readiness, and alignment with IEC 62304 and ISO 14971.

As a critical supplier, we integrate QA engineering services across the entire lifecycle, reducing safety and regulatory risks, ensuring user acceptance, and avoiding late-stage redesigns.

Common QA & testing challenges in MedTech

  • QA activities introduced too late result in audit risks

  • Testing isn’t aligned with IEC 62304

  • Documentation created after development, leading to gaps and rework

  • Lack of end-to-end visibility across requirements, code, and results

  • Missing documentation and traceability

  • Difficulty in selecting appropriate testing

  • Increasing complexity of multi-platform systems without a strategy

Our QA & testing services

  • End-to-end quality assurance

  • Full testing spectrum

  • Support in User Acceptance Testing

  • White box, black box, and grey box testing

  • CI/CD and automation

  • Compliance with regulatory requirements

  • Tried & tested technologies

  • Traceability and completeness report

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End-to-end quality assurance

Build high-quality, audit-ready, and safe systems by involving our QA engineers from the very beginning of your delivery process. Reduce the possibility of defects, compliance gaps, and delayed releases.

Our QA engineers work across the entire software lifecycle: from design and refinement to development, code review and testing. Verifying requirements, supporting traceability between code and test, and validating the software through risk-based checks, automated and manual testing.

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Full testing spectrum

Ensure reliable platform performance by validating it across all levels, preventing post-release defects and functional issues.

We cover the full testing spectrum, from automated unit and integration tests to system-level verification. Including functional and non-functional (e.g., performance, security, usability) testing, supported by regression, re-testing, and risk-based tests tailored to the specific needs of your project.

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Support in User Acceptance Testing

Achieve smooth and successful software adoption by User Acceptance Testing (UAT) with the professional guidance of our QA engineers. So you receive positive feedback from your users.

We support you throughout the UAT with your users, providing expertise, best-practice guidance, and structured approach to ensure it’s carried out effectively and efficiently.

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White box, black box, and grey box testing

Catch hidden issues early with advanced grey-box testing, making certain your product is reliable and deployment-ready.

Our grey-box testing complements white-box and black-box testing, uncovering potential issues. Thanks to close collaboration with software developers, we guarantee comprehensive checks and faster issue resolution.

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CI/CD and automation

Accelerate your development process while maintaining full control over software quality and stability by introducing automated verification and continuous integration.

We design and implement CI/CD pipelines tailored to your project, enabling automated testing and repeatable quality control checks. This way, every change is verified early and traceable per IEC 62304, reducing the risks that might become issues after release.

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Compliance with regulatory requirements

Avoid regulatory noncompliance and audit issues by aligning your medical device with key EU and US requirements and securing your project is compliant.

We operate within our ISO 13485-certified QMS and meet the regulatory requirements of IEC 62304, the Medical Device Regulation, GDPR, and HIPAA. Our QA engineers also follow OWASP practices and structure our testing activities in line with ISO 29119-1.

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Tried & tested technologies

Rely on proven, secure technologies, selected to meet quality and compliance expectations as a part of our QA testing services. Mitigate the risks of unreliable automation and compliance gaps.

We use industry-established tools such as Playwright, Jest, pytest, Bruno (alternative to Postman), and Locust, carefully customised to the needs and regulatory context of your project.

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Traceability and completeness report

Prevent audit issues and delays by providing traceability of every QA activity throughout the development process, ensuring your medical software is fully market-ready.

Following each release, we provide comprehensive reports that capture defects, test results, quality control outcomes, and actionable insights from our QA engineers, supporting decisions and improvements across your engineering workflows.

Discuss QA & testing in your project

Schedule a meeting with our experts and discuss your project’s needs and requirements.

What you get working with us

  • Compliance with IEC 62304

  • Reduced regulatory and project hazards

  • Support across functional, non-functional, and automated testing

  • Risk-based, gray-box approach

  • Incidents management in line with IEC 62304

  • Guidance through the development

How do we work with you?

We serve as your critical medical software supplier within your quality and regulatory framework, while you remain the legal manufacturer responsible for the device. This supports audit readiness and reduces the risks between software lifecycle and compliance.

QA & testing services are integral parts of our development process, not separate activities. We adapt our activities to your project’s specific technical and regulatory requirements, such as compliance with IEC 62304, ISO 14971, and ISO 27001, as well as performance, security, and interoperability expectations.

Case studies

Check out how we work through real-life projects:

About Revolve Healthcare

A QA & testing partner for reliable, audit-ready medical software

As a QA testing services company, we deliver the quality and safety of medical software through comprehensive QA engineering. We help you detect issues early, validate system performance, and ensure that user needs are met by applying best practices in medical device development.

We embed quality assurance into our process from day one. Operating within an ISO 13485-certified QMS and using our Agile 62304 framework to align our activities with IEC 62304, ISO 27001, ISO 14971, ISO 29119-1, and IEC 62366.

We have contributed to more than ten MDR- and IVDR-aligned software projects, covering end-to-end development and legacy systems refactoring.

Secure your software quality, performance, and compliance with expert QA & testing services.

During a 45-minute free-call you will:

  • clarify your current QA processes

  • understand regulatory and quality assurance expectations

  • get answers to your questions about our QA & testing.

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