Clinical Evidence

Regulatory3

• ISO 20916
• NMPA Innovative Medical Device Pathway
• Summary of Safety and Clinical Performance(SSCP)

Quality & Risk1

• Post-Production Information (Risk)

Clinical & Trials32

• Adaptive Trial Design
• Adverse Event(AE)
• ALCOA+
• Analytical Sensitivity
• Bayesian Trial Design
• Blinding and Masking
• Clinical Evaluation Report(CER)
• Clinical Investigation Plan(CIP)
• Composite Endpoint
• Data Safety Monitoring Board(DSMB)
• Early Feasibility Study(EFS)
• Feasibility Study
• First-in-Human Study(FIH)
• Human Factors Engineering(HFE)
• ICH E6 Good Clinical Practice(GCP)
• IDE Supplement
• Informed Consent
• Institutional Review Board(IRB)
• Intent-to-Treat vs Per-Protocol(ITT / PP)
• Investigational Device Exemption(IDE)
• Limit of Detection / Limit of Quantitation(LoD / LoQ)
• Lost to Follow-up
• Minimal Clinically Important Difference(MCID)
• Pivotal Trial
• Propensity Score Methods
• Protocol Deviation
• Real-World Evidence(RWE)
• Serious Adverse Event(SAE)
• Sham Control
• Source Data Verification(SDV)
• Surrogate Endpoint
• Use Error

Standards2

• Essential Performance
• ISO 14155

Software & AI4

• Algorithmic Bias and Fairness
• Clinical Decision Support(CDS)
• Foundation Model (Healthcare)
• Generative AI in Medical Devices

Post-Market1

• Post-Market Clinical Follow-up(PMCF)

Market Segments3

• Clinical Laboratory Improvement Amendments(CLIA)
• Remote Patient Monitoring(RPM)
• Wearables and Remote Patient Monitoring(RPM)

Reimbursement5

• Coverage with Evidence Development(CED)
• Health Technology Assessment(HTA)
• Joint Clinical Assessment(JCA)
• Protecting Access to Medicare Act(PAMA)
• RWE for Reimbursement

Commercialization3

• Field Clinical Engineer(FCE)
• Good Clinical Practice(GCP)
• Pre-Submission Meeting(Q-Sub)

Industry Bodies1

• Contract Research Organization(CRO)

Other ecosystems