Healthcare & Life Sciences
Software Quality for Healthcare That Puts Patient Safety First
From EHR platforms to medical devices, our specialist QA teams understand the regulatory landscape and the critical importance of getting it right.
The challenge
Why Healthcare & Life Sciences demands specialist QA
In healthcare, a software defect is not just a bug—it can affect patient outcomes. Our QA engineers work within HIPAA, GDPR, FDA 21 CFR Part 11, ISO 13485, and NHS DTAC frameworks to deliver software you can trust with lives.
What we solve
The testing challenges in Healthcare & Life Sciences
These aren't theoretical problems. They're the defects, failures, and compliance gaps that have cost companies in your sector real money.
Patient Safety & Data Integrity
Errors in clinical decision support, dosage calculators, or EHR data can directly harm patients. Software must be exhaustively validated before deployment.
Regulatory Validation (IQ/OQ/PQ)
FDA, NHS, and EU MDR frameworks require formal Installation, Operational, and Performance Qualification documentation. We produce compliant validation artefacts.
Interoperability & HL7/FHIR
Healthcare systems must communicate reliably. We test HL7, FHIR, and DICOM integrations to ensure data flows accurately across the care pathway.
Accessibility for Clinical Users
Clinical staff use software under pressure. We test usability and WCAG compliance to ensure interfaces don't create friction in time-critical environments.
Our approach
Services for Healthcare & Life Sciences
QA Testing
Comprehensive manual and exploratory testing to catch bugs before they reach your users. Our QA engineers become an extension of your team.
Learn moreAccessibility Testing
WCAG 2.2 compliance testing and remediation to ensure your product is usable by everyone, meeting legal obligations and expanding your audience.
Learn moreSecurity Testing
OWASP-aligned penetration testing and vulnerability assessments that protect your application and your users' data.
Learn moreTest Automation
Build robust automated test suites that integrate with your CI/CD pipeline, reducing regression risk and accelerating release cycles.
Learn moreOur process
How we get started
We've onboarded hundreds of clients in regulated industries. Here's how we go from first conversation to delivering value.
Discovery & Scoping
We learn your systems, your regulatory environment, and your biggest quality risks. This shapes everything we do.
Team Assembly
We assign engineers with direct experience in healthcare & life sciences so they hit the ground running—no generic testers learning on your time.
Delivery & Iteration
We integrate with your workflow, deliver tested software on your schedule, and continuously refine our approach based on findings.
Not sure where to start?
Book a 30-minute discovery call. No pitch, just honest answers about whether we're the right fit.
Book a callCommon questions
Healthcare & Life Sciences QA — answered
Yes. We have QA consultants with direct experience in FDA 21 CFR Part 11, ISO 13485, EU MDR, and MHRA submissions. We produce compliant validation documentation (IQ/OQ/PQ, traceability matrices, risk registers).
We have extensive experience testing Software as a Medical Device (SaMD) across diagnostic, monitoring, and therapeutic categories, aligned to IEC 62304 software lifecycle requirements.
We never use real patient data. We work exclusively with anonymised, synthetic, or de-identified datasets. We operate under full NDAs and are experienced working in HIPAA-compliant and ISO 27001 environments.
Ready to raise quality in Healthcare & Life Sciences?
Let's talk about your specific challenges. In 30 minutes we can give you an honest assessment and a clear recommendation.