--- title: "Clinical Evidence - MedTech Ecosystems" description: "How devices generate the clinical evidence regulators and payers demand - IDE studies, pivotal trials, real-world evidence, ISO 14155, and human-factors…" lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All ecosystems](/ecosystems) Ecosystem # Clinical Evidence How devices generate the clinical evidence regulators and payers demand - IDE studies, pivotal trials, real-world evidence, ISO 14155, and human-factors validation. 81 terms ## Regulatory6 - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [ISO 20916 ](/terms/iso-20916) - [NMPA Innovative Medical Device Pathway ](/terms/nmpa-innovation) - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) ## Quality & Risk1 - [Post-Production Information (Risk) ](/terms/post-production-info) ## Cybersecurity2 - [Medjacking ](/terms/medjacking) - [MITRE ATT&CK(ATT&CK) ](/terms/mitre-attack) ## Clinical & Trials49 - [Adaptive Trial Design ](/terms/adaptive-trial) - [Adverse Event(AE) ](/terms/adverse-event) - [ALCOA+ ](/terms/alcoa-plus) - [Analytical Sensitivity ](/terms/analytical-sensitivity) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Blinding and Masking ](/terms/blinding) - [Case Report Form(CRF) ](/terms/case-report-form) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Clinical Evaluation Report(CER) ](/terms/cer) - [Clinical Investigation Plan(CIP) ](/terms/cip) - [Composite Endpoint ](/terms/composite-endpoint) - [Data Safety Monitoring Board(DSMB) ](/terms/dsmb) - [Decentralized Clinical Trial(DCT) ](/terms/decentralized-clinical-trial) - [Early Feasibility Study(EFS) ](/terms/efs) - [Electronic Data Capture(EDC) ](/terms/edc) - [Feasibility Study ](/terms/feasibility-study) - [First-in-Human Study(FIH) ](/terms/fih) - [Human Factors Engineering(HFE) ](/terms/human-factors) - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [IDE Supplement ](/terms/ide-supplement) - [Informed Consent ](/terms/informed-consent) - [Institutional Review Board(IRB) ](/terms/irb) - [Intent-to-Treat vs Per-Protocol(ITT / PP) ](/terms/itt-pp) - [Investigational Device Exemption(IDE) ](/terms/ide) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Limit of Detection / Limit of Quantitation(LoD / LoQ) ](/terms/lod-loq) - [Lost to Follow-up ](/terms/lost-to-followup) - [Master Protocol (Basket / Umbrella / Platform) ](/terms/master-protocol) - [Minimal Clinically Important Difference(MCID) ](/terms/mcid) - [Non-Inferiority Trial ](/terms/non-inferiority-trial) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Pivotal Trial ](/terms/pivotal-trial) - [Pragmatic Trial ](/terms/pragmatic-trial) - [Primary and Secondary Endpoints ](/terms/primary-secondary-endpoint) - [Propensity Score Methods ](/terms/propensity-score) - [Protocol Deviation ](/terms/protocol-deviation) - [Real-World Data(RWD) ](/terms/rwd) - [Real-World Evidence(RWE) ](/terms/real-world-evidence) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Sample Size and Statistical Power ](/terms/sample-size-power) - [Serious Adverse Event(SAE) ](/terms/sae) - [Sham Control ](/terms/sham-control) - [Source Data Verification(SDV) ](/terms/sdv) - [Surrogate Endpoint ](/terms/surrogate-endpoint) - [Trial Master File(TMF) ](/terms/trial-master-file) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [Use Error ](/terms/use-error) ## Standards3 - [Essential Performance ](/terms/essential-performance) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [ISO 14155 ](/terms/iso-14155) ## Software & AI4 - [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) - [Clinical Decision Support(CDS) ](/terms/cds) - [Foundation Model (Healthcare) ](/terms/foundation-model-health) - [Generative AI in Medical Devices ](/terms/generative-ai-devices) ## Post-Market1 - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) ## Market Segments3 - [Clinical Laboratory Improvement Amendments(CLIA) ](/terms/clia) - [Remote Patient Monitoring(RPM) ](/terms/remote-patient-monitoring) - [Wearables and Remote Patient Monitoring(RPM) ](/terms/wearables-rpm) ## Reimbursement8 - [CMS IDE Coverage (Category A & B) ](/terms/ide-coverage) - [Coverage with Evidence Development(CED) ](/terms/ced) - [Health Economics and Outcomes Research(HEOR) ](/terms/heor) - [Health Technology Assessment(HTA) ](/terms/hta) - [Joint Clinical Assessment(JCA) ](/terms/jca) - [Proprietary Laboratory Analyses Codes(PLA) ](/terms/pla-codes) - [Protecting Access to Medicare Act(PAMA) ](/terms/pama) - [RWE for Reimbursement ](/terms/real-world-evidence-reimbursement) ## Commercialization3 - [Field Clinical Engineer(FCE) ](/terms/field-clinical-engineer) - [Good Clinical Practice(GCP) ](/terms/gcp) - [Pre-Submission Meeting(Q-Sub) ](/terms/pre-submission) ## Industry Bodies1 - [Contract Research Organization(CRO) ](/terms/cro) ### Other ecosystems [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)[Manufacturing & Supply](/ecosystems/manufacturing-supply) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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