Discovery Call
We learn your platform, tech stack, and testing priorities in a focused 30-minute session.
Devices and software should stay in sync with the bedside
Testiva delivers specialist QA for MedTech, connected devices, and SaMD — pairing, alarms, OTA updates, and companion apps validated under realistic clinical stress.
90%
Fewer Critical Bugs
3x
Faster Release Cycles
40%
Lower Rework Costs
Why it matters
What happens when MedTech and medical device software
What happens when MedTech and medical device software
isn't tested properly
In medical devices, a software failure isn't just a product defect, it's a patient safety event, a regulatory recall, or a liability case that no amount of post-market surveillance can undo.
Sensor & measurement inaccuracy
Incorrect readings from glucose monitors, pulse oximeters or infusion pumps don't just produce bad data — they drive clinical decisions that directly affect patient outcomes.
Firmware & software update failures
Poorly validated OTA updates that brick devices, corrupt calibration data or introduce regressions in safety-critical functions put patients at immediate risk in the field.
Alarm & alert system failures
Missed threshold alerts, false alarm suppression or delayed notification delivery in ICU monitors and implantable devices can have life-threatening consequences within minutes.
Regulatory non-compliance
Shipping device software without IEC 62304, FDA 21 CFR Part 11 or MDR-compliant documentation doesn't just delay approval — it can trigger market withdrawal and enforcement action.
How Testiva protects your platform
- Medical device software expertise — Our QA engineers specialise in SaMD, firmware and clinical device testing, not generic software QA repurposed for regulated environments.
- Standards-aligned test design — IEC 62304, ISO 14971, FDA 21 CFR Part 11 and EU MDR requirements built into every test case by design, not added as an afterthought.
- Hardware-in-the-loop testing — We test software against real device hardware, sensor inputs and communication protocols — not just simulated environments.
- Risk-based test prioritisation — Every test case is mapped to your risk management file so coverage decisions are always traceable to patient safety impact.
- Regulatory documentation support — We produce IQ/OQ/PQ protocols, software validation reports and traceability matrices audit-ready for FDA and notified body submissions.
What we test
MedTech & Medical Device Testing
Core areas of MedTech and medical device software we cover Sub: Every layer of your device software stack is validated, stress-tested, and verified against clinical requirements, safety standards and regulatory expectations.
Sensor data acquisition & accuracy
Validating reliable sensor measurements, calibration accuracy and signal integrity under varying conditions.
Alarm & alert system validation
Testing accurate alert triggering, prioritisation and notification reliability across failure scenarios.
Firmware & OTA update integrity
Ensuring secure firmware updates, rollback reliability and post-update system stability.
Device communication & connectivity
Verifying stable device pairing, data transmission integrity and reconnection behaviour across protocols.
Clinical data display & rendering
Testing accurate waveform rendering, trend visualisation and critical value display behaviour.
SaMD algorithm & decision support validation
Validating diagnostic algorithm accuracy, AI/ML performance and edge case reliability.
Cybersecurity & attack surface testing
Ensuring secure authentication, encrypted communication and resilience against cyber threats.
Regulatory & standards compliance
Verifying compliance readiness across FDA, IEC, ISO and EU MDR regulatory requirements.
Performance, reliability & fault tolerance
Testing long-term stability, fault tolerance and system reliability under continuous operation.
HOW IT WORKS
Up and running in 4 simple steps
From first contact to your first test report — a process designed to be fast, transparent and low-friction.
QA Audit & Plan
We audit your current test coverage and deliver a tailored testing strategy and test case plan.
Test Execution
Our team runs manual and automated tests, logging every defect with full reproduction steps.
Report & Iterate
You receive a detailed report with severity ratings, trends, and recommendations for the next sprint.
What People Say
“Testiva is a great team to work with. I’ve hired them multiple times and recommended them to others, all impressed by their thorough work. Highly recommended for QA.”
“Testiva team is highly skilled and extremely thorough. I trust them for accurate and timely delivery. They are a reliable resource for any project.”
“Testiva team delivered outstanding quality with great professionalism. Communication was excellent and delivery met expectations. Highly recommended.”
“Excellent team worked well with minimal supervision and did a great job. Their work helped us improve the robustness of the platform.”
MedTech & Medical Devices Software
Testing Packages
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| Functional & UI testing |  |
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| Mobile — iOS & Android | 2 dev | 4 dev | 4 dev | 4 dev |
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| Performance / load testing | |
5k | 10k | Unlimited |
| Test automation framework | |
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Setup | Full build |
| CI/CD pipeline integration | |
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| MEDTECH / MEDICAL DEVICES SPECIFIC | ||||
| Device connectivity & pairing QA | |
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| Sensor data accuracy & calibration testing | |
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| Real-time data capture & transmission QA | |
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| Alerts, alarms & threshold notification QA | |
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| User roles & access control | |
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| Device firmware & software update testing | |
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| Remote patient monitoring & data sync | |
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| Device lifecycle & inventory management QA | |
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| Multi-device & cross-platform compatibility | |
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| Reporting & analytics dashboard QA | |
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| Interoperability — EHR, FHIR & HL7 integration | |
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| Clinical data integrity & audit trail QA | |
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| AI/ML diagnostic & predictive model validation | |
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| Offline mode & disconnection resilience QA | |
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| Localization & multi-language testing | |
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| COMPLIANCE & SECURITY | ||||
| FDA 21 CFR Part 11 & SaMD readiness | |
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| HIPAA & data privacy compliance testing | |
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| Cybersecurity & pen testing (MDCG guidelines) | |
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| ISO 13485 quality management readiness | |
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| SUPPORT & REPORTING | ||||
| Dedicated QA lead | |
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| 24/7 critical defect SLA | |
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Get in touch
Start with a discovery call
Tell us about your device, companion app, or SaMD and we'll map out exactly what testing you need — no obligation.
Email us
Book a call
30-minute discovery sessions available Mon–Fri
Fast response
We reply to all enquiries within 1 business day