Claims-to-evidence matrix
Intended use, target population, clinical setting, outputs, endpoints and benefit-risk questions mapped to available and needed evidence.
Clinical Evidence Strategy
Clinical evidence support for medical devices.
We help SaMD teams define what must be demonstrated, evaluate existing evidence, design a proportionate evidence plan and prepare regulatory documentation. We do not operate clinical sites or represent document support as clinical trial conduct.
Selected clients
Healthcare teams we have supported
Scope and deliverables
Clinical evidence work included in the service.
Our scope covers regulatory evidence strategy, synthesis and documentation. Site selection, participant recruitment, study conduct, monitoring, biostatistical programming and data management require qualified providers under separate responsibility.
Evidence landscape and gaps
Structured inventory of product data, literature, comparator evidence, analytical validation, usability and real-world information with limitations made explicit.
Literature review methods
Search protocol, databases, terms, screening criteria, appraisal framework, extraction structure and reproducible update plan.
Clinical evaluation documentation
EU MDR clinical evaluation plan and report support, equivalence assessment inputs, state-of-the-art narrative and linkage to risk and PMS.
Study concept and protocol inputs
Regulatory objectives, population, endpoints, comparator, bias controls, sample-size assumptions and analysis considerations for discussion with clinical and statistical specialists.
Submission and PMCF integration
Evidence summaries for FDA or EU dossiers, response support, residual-gap rationale and post-market clinical follow-up planning.
Ways to work together
Choose the support your team needs.
Evidence strategy sprint
A focused claims, gap and regulatory-question assessment before a study or submission plan is fixed.
CER documentation support
Methodical clinical evaluation planning, literature work and report drafting with manufacturer review and approval.
Specialist coordination
Work alongside the sponsor’s clinicians, statistician, CRO, investigators and regulatory lead with explicit interfaces and ownership.
How it works
Our process.
- 1
Frame the question
Define intended use, claims, population, context, benefit, risk and pathway.
- 2
Appraise evidence
Assess relevance, quality, bias, applicability and gaps across evidence sources.
- 3
Plan generation
Specify proportionate methods and qualified delivery roles for unresolved questions.
- 4
Document and update
Build controlled regulatory outputs and connect them to PMS and change triggers.
Regulations, standards and guidance considered
EU MDR Articles 61 & 62EU MDR Annex XIVMDCG 2020-1MEDDEV 2.7/1 rev. 4FDA SaMD Clinical Evaluation GuidanceISO 14155ISO 14971IMDRF SaMD N41
Frequently asked questions
Questions teams ask before they begin.
Does Predetics run clinical sites or recruit participants?+
No claim is made that we operate sites, recruit participants or act as a CRO. We support regulatory evidence strategy and documentation and can work with the sponsor’s qualified clinical, statistical, data-management and site partners.
Does every SaMD need a clinical investigation?+
No. The need depends on claims, risk, novelty, available evidence and pathway. Literature, analytical studies, usability evidence or existing clinical data may answer some questions; a prospective study is warranted when material uncertainty remains.
Can published literature establish clinical evidence?+
Sometimes, but relevance and quality must be demonstrated. Differences in device, algorithm, data provenance, population, workflow and endpoint can limit applicability. Literature should not be used to bridge product-specific performance without a defensible rationale.
What is the difference between analytical and clinical validation?+
Analytical validation asks whether the software correctly processes inputs and produces accurate outputs. Clinical validation or performance asks whether those outputs achieve the stated purpose in the target population and use context. Both may be necessary.
Can equivalence avoid new EU clinical data?+
Only where equivalence can be robustly demonstrated across technical, biological and clinical characteristics and sufficient access to relevant data exists. For many software devices, changes in data, algorithm or workflow make equivalence difficult.
Can evidence sufficiency or authorization be guaranteed?+
No. Authorities and notified bodies evaluate evidence in context. We document assumptions, limitations and residual uncertainty and recommend early feedback where the evidence threshold is genuinely uncertain.
Start with the product you have