All MedTech Terms
380 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–24 of 32
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.
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).
Data Safety Monitoring Board(DSMB)
Independent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial.
Early Feasibility Study(EFS)
FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.
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 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.
Institutional Review Board(IRB)
Board that reviews and approves human-subjects research at an institution.
Intent-to-Treat vs Per-Protocol(ITT / PP)
Two analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol.
Investigational Device Exemption(IDE)
FDA authorization to use an investigational device in a clinical study.
Limit of Detection / Limit of Quantitation(LoD / LoQ)
Lowest analyte concentrations an assay can reliably detect (LoD) or quantify (LoQ).
Lost to Follow-up
Subjects whose outcome data are missing because they did not complete planned visits.
Minimal Clinically Important Difference(MCID)
Smallest change in a measurement that patients perceive as clinically meaningful.
Pivotal Trial
Definitive clinical study designed to establish safety and effectiveness for marketing authorization.