What the programme covers
Medical-device evidence must connect the intended use, target population, care setting, input data and output to a study design. A technically clean dataset is insufficient if patient selection or reference truth does not support the proposed claim.
What a useful specification includes
A defensible request defines the clinical task, source evidence and acceptance criteria before patient-level data moves. The exact fields and thresholds depend on the intended model claim.
- Intended use, user and care setting
- Target population and contraindications
- Device input and acquisition constraints
- Reference standard and adjudication
- Study endpoints and statistical plan
- Locked data, software and analysis versions
Quality and validation controls
Evidence programmes prioritize reproducibility and change control. Cohort definitions, ground truth, transformations, model version and analysis outputs remain linked for review.
- Protocol-aligned cohort selection
- Reference-standard documentation
- Site, device and subgroup representation
- Locked releases and audit trail
- Deviation, exclusion and missing-data records
Availability, rights and delivery
MedCorpora can provide controlled data and lineage evidence under programme terms, but does not promise regulatory clearance or replace sponsor, legal, clinical, statistical or regulatory responsibilities.
Public pages describe a sourcing and engineering capability, not guaranteed ready inventory. Each release remains subject to verified programme inventory, programme-specific authorization, privacy review, technical acceptance and buyer licence terms.
Questions, answered directly.
Does MedCorpora provide regulatory approval?+
No. Regulators and applicable authorities determine acceptance; MedCorpora provides data infrastructure and programme evidence.
Can a cohort be locked before evaluation?+
Yes. Release versions and manifests can be frozen and recorded before analysis.
Can reference standards include adjudication?+
Yes when the task requires multiple reviewers or a defined resolution process.
Can post-deployment monitoring data be scoped?+
Potentially as a separate programme with its own authority, outcomes, monitoring protocol and release controls.