Medical device evidence & validation consulting
Build evidence that supports the intended use.
Zaliance helps teams connect product claims with evaluation methods, acceptance criteria, and documented conclusions.
Support includes evidence planning and review for cardiovascular devices and medical device software, with particular depth in ECG analytics and wearable recording technologies.
Evidence strategy
Determine what the evaluation needs to demonstrate and how existing evidence contributes. Consider the intended population, use environment, relevant endpoints, and limitations of the available data.
Deliverables may include: evidence-gap assessments, evaluation strategies, and claim-to-evidence mappings.
Protocols & acceptance criteria
Develop or review evaluation protocols with attention to reference methods, data selection, endpoints, acceptance criteria, and statistical interpretation.
Deliverables may include: validation protocols, performance evaluation plans, and technical review comments.
ECG device & configuration performance
Plan evaluations that account for differences in recording technology, electrode placement, input configuration, signal quality, and recording duration.
Assess device-level and configuration-level results alongside overall performance to understand whether the evidence supports the proposed compatibility claims.
Deliverables may include: source-qualification plans, configuration comparisons, and performance assessments.
Clinical evaluation & literature assessment
Review clinical evidence in relation to the device’s intended purpose, safety, performance, and claims. Identify where the evidence is sufficient and where additional work is needed.
Deliverables may include: clinical evaluation plans and reports, literature assessments, and evidence summaries.
Reports & interpretation
Review whether results answer the evaluation questions and whether conclusions reflect the methods, findings, and limitations.
Deliverables may include: validation reports, technical summaries, and recommendations for additional evaluation.
Evidence insights
A closer look at evaluation methods, clinical claims, and the interpretation of performance results.
ECG & evidence
AI and sudden cardiac death: what should clinicians do with an ECG risk prediction?
A Nature study identifies an ECG signal associated with future sudden cardiac death. Its findings raise a practical development question: what action should a risk prediction support, and what evidence would justify…
ECG & evidence
Clinical evidence planning starts with the intended use
A well-run study can still leave a device claim unanswered. Map intended use to population, outcomes and evidence gaps before deciding which clinical work to commission.
ECG & evidence
Bench, analytical and clinical evidence in a cardiovascular program
A cardiovascular device company faces complex decisions despite successful engineering results. Testing outcomes need clarity regarding their clinical relevance versus technical validation. Understanding distinctions between physical endurance, measurement accuracy, and clinical impact…