Discovery Call
We learn your CDSS platform, clinical use cases, alert logic, EHR integrations, and regulatory obligations in 30 minutes.
Clinical decision support systems deserve evidence grade validation
Testiva delivers specialist QA for CDSS platforms, diagnostic accuracy, alert logic, recommendation safety, and FDA AI/ML compliance.
150+
CDSS Scenarios Evaluated
3x
Faster Release Cycles
40%
Lower Rework Costs
Why it matters
What happens when Clinical Decision
What happens when Clinical Decision
Support Systems aren’t tested properly
Incorrect diagnostic suggestions reach clinical workflows
A CDSS surfacing an unvalidated diagnosis at high confidence influences clinical care decisions silently.
Alert logic fires incorrectly or creates alert fatigue
A wrong severity alert erodes clinical trust until clinicians dismiss every alert including the critical ones.
CDSS recommendations biased across patient demographics
AI tools trained on imbalanced datasets produce differential recommendations across age, gender, and ethnicity.
No FDA AI/ML validation evidence for clinical deployment
FDA and NHS regulators ask for clinical AI validation evidence teams discover they lack only at submission time.
How Testiva protects your Clinical Decision Support System
- Clinical QA engineers who understand diagnostic reasoning — We evaluate recommendations against evidence-based clinical standards, not just whether one was generated.
- Alert logic tested against clinical urgency standards — Every alert rule and threshold validated against clinical standards measuring missed alerts and fatigue risk.
- Adversarial recommendation safety testing — We test contraindicated scenarios and high-risk presentations where the CDSS must decline rather than recommend.
- Clinical AI bias testing across patient populations — Differential recommendation analysis across age, gender, ethnicity, and comorbidity ensuring equitable support.
- FDA AI/ML and MHRA AIaMD validation evidence from day one — Regulatory traceability documentation produced throughout the engagement ready before a reviewer asks for it.
What we test
Core components of a Clinical Decision Support System we cover
Every layer that affects diagnostic accuracy, alert reliability, and clinical safety is validated against evidence-based standards and regulatory requirements.
Diagnostic Suggestion Accuracy
Rankings validated against clinical ground truth.
Clinical Alert Logic & Severity
Alert thresholds tested against clinical urgency standards.
Recommendation Safety & Adversarial
Contraindicated scenarios tested for safety boundaries.
Clinical AI Bias & Health Equity
Differential recommendations measured across demographics.
EHR Data Quality & Input Validation
Model behaviour tested with malformed EHR inputs.
Recommendation Regression Testing
Accuracy re-evaluated on every model and rule change.
Post-Deploy Drift Monitoring
Recommendation patterns tracked against validated baselines.
Regulatory & Compliance Validation
FDA and MHRA evidence mapped throughout the engagement.
Performance Under Clinical Load
Response times verified under clinical session load.
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 recommendation accuracy baseline, alert logic coverage, and build a clinical validation strategy with ground truth datasets.
Test Execution
Diagnostic accuracy evaluation, alert logic testing, adversarial safety scenarios, bias analysis, and regulatory mapping every defect rated by clinical severity.
Report & Iterate
Clinical accuracy report with recommendation quality metrics, alert logic findings, bias analysis, regulatory traceability, and prioritised remediation roadmap.
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.
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CDSS Testing Packages
| Feature | Starter | Professional | Clinical | Enterprise |
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| CORE CDSS TESTING | ||||
| Diagnostic suggestion accuracy testing |  |
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| Clinical alert logic & severity testing | |
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| EHR data quality & input validation | |
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| Clinical scenario coverage testing |  |
5K scenarios | 10K scenarios | Unlimited |
| Multi-specialty recommendation testing | |
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Setup only | Full build |
| CLINICAL SAFETY & BIAS | ||||
| Clinical ground truth dataset build | |
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| Recommendation safety & adversarial testing | |
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| Clinical AI bias & health equity testing | |
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| Alert fatigue & over-alerting analysis | |
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| COMPLIANCE, MONITORING & INTEGRATIONS | ||||
| HIPAA & PHI data handling audit | |
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| FDA AI/ML validation evidence | |
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| MHRA AIaMD & NHS AI governance | |
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| Recommendation regression pipeline | |
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| Post-deploy drift monitoring | |
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| SUPPORT & REPORTING | ||||
| Dedicated clinical QA lead | |
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| CDSS accuracy scorecard & weekly report | |
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| 24/7 critical patient safety defect SLA | |
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Common questions
We build synthetic clinical case libraries that replicate real patient presentations across condition categories, comorbidities, and demographic profiles. These are validated against current clinical guidelines and diagnostic standards before use. Real patient data never enters our test environments we work with your de-identification protocols if you have existing EHR data you wish to use under a formal data handling agreement.
We test both directions of alert failure simultaneously. For missed alerts, we design clinical scenarios where an alert should fire and verify that it does at the correct severity level. For over-alerting and alert fatigue, we test clinical presentations where an alert should not fire and measure false positive rates by condition category and alert type. We also test alert suppression logic, severity escalation thresholds, and the specific comorbidity combinations where alert rules most commonly interact unexpectedly.
Adversarial safety testing presents the CDSS with clinical scenarios where a recommendation should not be generated known contraindications, conflicting drug combinations, incomplete clinical inputs, and high-risk patient presentations where the correct system behaviour is to decline, escalate, or flag uncertainty rather than produce a confident recommendation. We specifically test the edge cases that only surface under adversarial conditions, not in the expected happy-path clinical scenarios covered by standard QA.
We run structured bias evaluation across age, gender, ethnicity, socioeconomic status, and comorbidity profile measuring whether the CDSS produces systematically different diagnostic rankings, recommendation confidence levels, or alert firing rates for equivalent clinical presentations across demographic groups. We report differential performance by subgroup and severity, quantify the equity gap, and help you trace it to training data, feature weighting, or model architecture to support remediation.
Model updates and clinical guideline changes are among the most common causes of silent recommendation regression in CDSS platforms. We establish a diagnostic accuracy and alert logic baseline and run automated regression testing against that baseline after every model update, alert rule modification, or knowledge base change detecting ranking shifts, new false positive alert patterns, and accuracy degradation before they reach clinical workflows or governance reviews.
Yes. Our CDSSShield and ApexCDSS Suite tiers include regulatory traceability documentation covering diagnostic accuracy baselines, alert logic validation records, bias audit findings, and drift monitoring protocols structured to support FDA AI/ML SaMD action plan requirements and MHRA AIaMD guidance for UK deployments. This documentation is produced as a standard output of the testing engagement, not a separate audit commissioned after submission review has already begun.
Get in touch
Start with a free CDSS QA audit.
Tell us about your Clinical Decision Support System and we’ll map out exactly what clinical testing you need no obligation, no sales pitch.
Email us
Book a call
30-minute sessions available Mon–Fri
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Fast response
We reply to all enquiries within 1 business day