All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–24 of 52
Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Adverse Event(AE)
Any untoward medical occurrence in a subject, whether or not related to the device.
ALCOA+
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
Analytical Sensitivity
An IVD's ability to detect small quantities of an analyte.
Bayesian Trial Design
Trial design that uses Bayesian statistics, often incorporating prior data from related studies or registries.
Blinding and Masking
Procedures that hide treatment assignment from patients, investigators, or assessors to reduce bias.
Case Report Form(CRF)
Structured paper or electronic forms used to capture protocol-required data for each enrolled subject.
Clinical Evaluation Plan(CEP)
EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
Clinical Evaluation Report(CER)
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Clinical Investigation Plan(CIP)
EU MDR's term for the protocol document governing a clinical investigation of a device.
Composite Endpoint
Single endpoint combining multiple component outcomes (e.g., MACE = death + MI + stroke).
Core Laboratory
An independent, centralized laboratory that performs standardized, blinded analysis of imaging or physiologic data from multiple trial sites to produce consistent endpoint adjudication.
Data Safety Monitoring Board(DSMB)
Independent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial.
Decentralized Clinical Trial(DCT)
A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
Early Feasibility Study(EFS)
FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.
Electronic Data Capture(EDC)
Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms.
Electronic Patient-Reported Outcome(ePRO)
A patient-reported outcome instrument administered and captured electronically, subject to validation and 21 CFR Part 11 data-integrity requirements when used in FDA-regulated trials.
Feasibility Study
Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.
First-in-Human Study(FIH)
First clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS.
Human Factors Engineering(HFE)
Engineering discipline focused on safe and effective device use by intended users.
ICH E6 Good Clinical Practice(GCP)
International standard for the design, conduct, and reporting of clinical trials.
IDE Annual Progress Report
Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events.
IDE Supplement
Amendment to an approved Investigational Device Exemption for protocol or device changes.
Informed Consent
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.