GLOSSARY
MEDICAL DEVICE TERMS AND DEFINITIONS
VERSION: 1.0
Welcome to the Medical Device Glossary, an essential resource designed to provide clarity and understanding for medical device innovators, manufacturers, and healthcare providers alike.
DATE: 30 AUG 2024
INTRODUCTION
WHY ARE MEDICAL DEVICE TERMS AND DEFINITIONS IMPORTANT?
In the dynamic field of medical technology, precise terminology is not merely a matter of communication; it forms the bedrock of safety, compliance, and innovation.
THE PURPOSE OF THE MEDICAL DEVICE GLOSSARY
This glossary aims to demystify the intricate language surrounding medical devices, offering concise definitions and explanations of key terms that span the entire device development and management lifecycle, from conceptualisation and design to manufacturing, regulation, and clinical management.
Whether you are navigating the complexities of regulatory requirements, ensuring quality standards in manufacturing, or seeking to enhance patient outcomes through innovative technology, this glossary serves as your trusted companion.
With contributions from experts in the field and regularly updated to reflect the latest advancements and regulatory changes, the Medical Device Glossary is your reliable gateway to mastering the language of medical technology. We invite you to explore, learn, and leverage this resource to advance your knowledge and expertise in the dynamic world of medical devices.
USER GUIDE
HOW TO USE THIS RESOURCE
Search and Navigation: Start by familiarising yourself with the structure of the glossary. This glossary is organised alphabetically, making it easy to locate specific terms. Related terms are cross-referenced for ease of navigation.
Definitions and Explanations: Each term in the glossary is accompanied by a general definition and, in some cases, additional explanations or context. These definitions aim to provide a basic understanding of the term. Formal definitions for some terms vary between jurisdictions and settings.
Contextual Use: Understand how each term is used within the context of medical devices. Some terms may have specific meanings or implications in different phases of device development (e.g., design, manufacturing, clinical trials) or regulatory processes (e.g., FDA requirements, CE marking).
Cross-Referencing: Use cross-references provided within the glossary to explore related terms. This can deepen your understanding of interconnected concepts and how they relate to each other within the medical device ecosystem.
Regulatory and Compliance Guidance: Pay attention to terms related to regulatory affairs and compliance standards. This glossary includes terms to help you navigate the regulatory landscape more effectively. However, precise definitions do vary by regulatory authority and in standards, so it’s important to reference the formal definitions included in relevant regulations and standards for regulatory submissions and documentation.
Training and Education: Glossaries are valuable tools for training new team members or educating stakeholders about medical device terminology. Incorporate the glossary into training programs to ensure consistency in understanding and communication across your organisation.
Updates and Revisions: Medical device technology evolves rapidly, and regulatory and payer requirements can change. Check the glossary periodically for updates and revisions to stay current with the latest terminology and industry practices.
Feedback and Contributions: If you encounter unclear or missing terms from the glossary, provide feedback to MedDev Central. Your input can help improve the glossary for future users.
TERMS AND DEFINITIONS
The following 14 pages contain a list of key medical device terms and definitions arranged alphabetically. They cover terms associated with:
• Medical Device Innovation (Research, Design and Development, Market Access and Commercialisation)
• Regulation and Quality
• Health Technology Assessment (HTA)
• Medical Device Management
510(k) Clearance: A premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA (Premarket Approval).
A
Acceptance Criteria: The predefined standards and specifications that a device must meet during testing and evaluation to be deemed suitable for its intended use and to comply with regulatory requirements.
Adverse Event: Any untoward medical occurrence in a patient or clinical investigation subject administered a medical device, which does not necessarily have to have a causal relationship with this treatment.
Audit: A systematic, independent examination of a manufacturer’s processes, procedures, and products to ensure compliance with regulatory standards and quality requirements. Also see Internal Audit.
Authorised Representative: A natural or legal person appointed by a manufacturer to act on their behalf in carrying out specific tasks related to conformity assessment and regulatory compliance.
B
Benefit-Risk Analysis: The comparison of a medical device’s benefits to its associated risks, often used in regulatory decision-making.
Biocompatibility: The ability of a material to perform with an appropriate host response when applied as intended.
Biomedical Engineer and Technician: Personnel that maintain and repair medical devices to ensure their proper functionality.
Budget Impact Analysis (BIA): A financial assessment tool used to estimate the cost implications of adopting a new healthcare intervention within a specific budget context over a defined time period.
C
CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Change Control: The systematic process of managing and documenting modifications to a device or its manufacturing process to ensure that all changes are assessed, approved, implemented, and tracked in compliance with regulatory standards and quality management systems.
Classification: The process of categorising devices into different classes based on their intended use, level of risk to patients and users, and regulatory controls necessary to ensure safety and effectiveness.
Cleanroom: A controlled environment with a low level of pollutants, such as dust, airborne microbes, aerosol particles, and chemical vapours used in manufacturing and scientific research.
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Clinical Evaluation Plan (CEP): A structured document outlining the methodology and objectives for assessing the clinical performance and safety of a medical device or intervention.
Clinical Evaluation Report (CER): A comprehensive document that systematically analyses clinical data pertaining to a medical device to establish its safety and performance per regulatory requirements.
Clinical Guideline: A systematically developed statement to assist healthcare practitioners and patients in making decisions about appropriate healthcare for specific clinical circumstances.
Clinical Investigation: Any systematic investigation or study in or on one or more human subjects undertaken to assess the safety or performance of a medical device.
Common Submission Dossier Template (CSDT): A standardised format for the submission of regulatory information for medical devices in ASEAN countries.
Competent Authority (CA): A national regulatory body responsible for regulating and overseeing the safety, efficacy, and quality of medical devices within its jurisdiction. Also see Regulatory Authority.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Conception The initial phase of product development, during which an idea is generated and conceptualised into a feasible product design, considering market needs, technical feasibility, potential benefits, and risks.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Contextual Inquiry: A field study method used to observe and interview users in their work environment to understand their needs and challenges.
Control Group: The group in a clinical study that receives a standard treatment, a placebo, or no treatment against which the experimental group’s outcomes are compared.
Control Measure: An action or activity that can prevent, eliminate or reduce a hazard to an acceptable level.
Corrective Maintenance: The process of diagnosing and repairing faults or failures to restore the device to its proper functioning condition.
Corrective and Preventive Action (CAPA): Actions taken to eliminate the causes of existing nonconformities or other undesirable situations (corrective actions) and to prevent recurrence (preventive actions).
Cost-Effectiveness Analysis (CEA): A method of evaluating healthcare interventions by comparing their costs in relation to their health outcomes, typically measured in terms of cost per unit of health improvement gained.
Cost-Benefit Analysis (CBA): A technique for assessing the financial feasibility of interventions by comparing their costs and benefits, where benefits are expressed in monetary terms.
Cost-Utility Analysis: A type of economic evaluation that compares the costs of healthcare interventions to their outcomes in terms of quality-adjusted life years (QALYs) gained, providing a measure of healthrelated quality of life.
DDecommissioning: The process of safely retiring or discontinuing the use of a device, ensuring proper disposal or reprocessing following regulatory and environmental requirements.
Design Control: A systematic process that ensures a device is designed to meet user needs and intended uses.
Design and Development Plan: A comprehensive document outlining the systematic process and stages, including timelines, responsibilities, and resources, required to bring a medical device from concept to market-ready product, ensuring compliance with regulatory standards.
Design Freeze: The point in the medical device development process where the design is finalised and no further changes are allowed, ensuring a stable basis for validation, regulatory submission, and production.
Design History File (DHF): A compilation of records that describes the design history of a finished device.
Device Master Record (DMR): A comprehensive collection of documents and records describing the medical device’s design, manufacturing, and quality control processes.
Device History Record (DHR): Report confirming that the device is produced according to the specifications in the DMR
Design Inputs: The physical and performance requirements of a device that are used as a basis for device design. Also known as Technical Specifications.
Design Outputs: The results of a design effort at each design phase and at the end of the total design effort used to evaluate conformance to design input requirements.
Design Review: A formal evaluation process to assess the completeness, feasibility, and compliance of a device’s design with specified requirements (design inputs).
Design Transfer: The process of transitioning a product’s design from development and manufacturing into production while ensuring all specifications and requirements are met.
Design Verification: The process of ensuring that design outputs meet design inputs.
Design Validation: The process of ensuring that devices conform to defined user needs and intended uses.
Distributor: A natural or legal person in the supply chain, other than the manufacturer or importer, who makes a medical device available on the market.
Economic Operator: Any person or entity engaged in the production, distribution, import, export, or supply of medical devices.
End-of-life: The stage in the medical device lifecycle when the manufacturer no longer supports the device due to obsolescence, discontinuation of production, or inability to provide necessary components or services.
Endpoint: The measurable result at the end of a study, including types such as:
• Clinical Endpoint: A precisely defined and measurable outcome used to determine the effect of an intervention.
• Performance Endpoint: A measure of how well the medical device achieves its intended purpose.
• Primary Endpoint: The main result that is measured at the end of a study to see if the treatment worked (e.g., the change in a clinical measurement from baseline to the end of the study).
• Safety Endpoint: A measure of the frequency and severity of adverse events experienced by participants during a clinical trial.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Economic Evaluation: The evaluation and analysis of the costs and consequences of using a medical device or intervention, often comparing different options to inform decision-making. This may also be called an Economic Assessment.
Ethics Committee (Institutional Review Board - IRB): An independent group that reviews and monitors the ethical aspects of a clinical trial.
FFault Tree Analysis (FTA): A top-down, deductive failure analysis used to determine the chain of events that could cause a system-level failure.
Failure Mode and Effects Analysis (FMEA): A systematic method for identifying potential failure modes of a device and assessing their potential effects on device performance and patient safety.
FDA Approval: The process by which the U.S. Food and Drug Administration (FDA) officially recognises that a medical device is safe and effective for its intended use.
Follow-Up: The period of observation of participants after the intervention has been applied.
Formative Evaluation: An early-stage usability testing process to gather feedback to inform design improvements.
Global Harmonisation Task Force (GHTF): Has been succeeded by the International Medical Device Regulators Forum (IMDRF).
Good Clinical Practice (GCP): An international quality standard provided by the International Conference on Harmonisation (ICH) for the conduct of clinical trials involving human subjects.
Good Manufacturing Practices (GMP): Regulations that require manufacturers to ensure products are consistently produced and controlled according to quality standards.
Go-to-Market Strategy: A comprehensive plan outlining how a company will introduce and promote its products or services to its target customers and achieve competitive advantage in the marketplace.
HHarm: Physical injury or damage to the health of people or damage to property or the environment.
Harmonisation: The process of aligning standards, requirements, and procedures across different jurisdictions to ensure consistent safety and efficacy evaluations and market access for medical devices.
Hazard: A potential source of harm.
Hazardous Situation: Circumstances in which people, property, or the environment are exposed to one or more hazards.
Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.
Healthcare Provider: An individual or organisation licensed or otherwise authorised to deliver medical, nursing, dental, or other healthcare services to patients or clients.
Health System: The organised network of institutions, resources, and people that deliver healthcare services to meet the health needs of a specific population.
Health Technology: The application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives (WHO definition).
Health Technology Assessment (HTA): A systematic evaluation of the properties, effects, and impacts of health technology, such as medical interventions, pharmaceuticals or medical devices, to inform healthcare decision-making.
Health Technology Management (HTM): The systematic planning, procurement, implementation, and evaluation of medical technologies to ensure their safe, effective, and efficient use within healthcare settings.
Heuristic Evaluation: A usability inspection method where experts use established heuristics or guidelines to identify usability problems.
High-Income Country (HIC): Countries defined based on their Gross National Income (GNI) per capita, where high-income countries have a GNI per capita above a specified threshold.
Human-Device Interaction: The interaction between the user and the medical device, including how the user perceives, interprets, and responds to the device’s signals and controls.
Human Factors Engineering (HFE): The application of knowledge about human abilities, limitations, and other characteristics to the design of medical devices, systems, and environments to ensure safe, comfortable, and effective use. Also see Usability Engineering.
I
Ideation: The creative process of generating, developing, and communicating new ideas.
Importer: A natural or legal person who places a device from another country on the market.
Indication of Use: A concise statement specifying the medical conditions or purposes for which the medical device is intended to be used, as approved by regulatory authorities.
Informed Consent: The process through which a participant voluntarily confirms their willingness to participate in a study after being informed of all study aspects relevant to their decision to participate.
Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
Internal Audit: A systematic, independent, and documented process conducted within an organisation to evaluate the effectiveness and compliance of its quality management system (QMS) with regulatory requirements and internal standards.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
Investigator: An individual who conducts a clinical investigation and is responsible for ensuring the study’s integrity and participants’ welfare. Also see Clinical Investigation.
Investigational Device Exemption (IDE): An exemption that allows a medical device to be used in a clinical study to collect safety and effectiveness data, typically required before a device can be marketed.
in vitro Diagnostics (IVD): Medical tests conducted on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections outside the body.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
ISO 14971: An international standard for the application of risk management to medical devices.
Inventory Management: The systematic planning and control of medical supplies, devices, and equipment to ensure availability, minimise waste, and optimise resource utilisation in healthcare settings.
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Low and Middle-Income Countries (LMICs): Countries defined based on their Gross National Income (GNI) per capita, where low-income countries have a GNI per capita below a specified threshold, and middle-income countries fall above that threshold but below the threshold for high-income countries.
MManufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Material Characterisation: The process of identifying and quantifying the chemical composition, structure, and properties of the materials used in a medical device.
Medical Device: An instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease. Each regulatory authority has a formal definition of a medical device, which should be referred to for regulatory compliance.
Medical Device Management System (MDMS): A comprehensive framework that oversees the lifecycle of medical devices from acquisition to disposal, ensuring regulatory compliance, safety, and operational efficiency.
Meta-Analysis: A statistical technique that combines the results of multiple scientific studies to integrate findings and derive overall conclusions about the effectiveness or impact of a health technology or intervention.
Mode of Action: The means by which a device achieves its intended therapeutic or diagnostic effect.
NNeeds Assessment: A systematic process to identify and prioritise gaps or requirements in healthcare delivery that could be addressed through technological interventions.
Notified Body (NB): An organisation designated by a country authority to assess the conformity of certain products before being placed on the market, ensuring they meet applicable regulatory requirements and standards.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Preventative Maintenance: Scheduled inspections, servicing, and adjustments performed regularly to prevent potential equipment failures and ensure continued reliability and safety in clinical settings.
Polymeric Degradation Products: Byproducts resulting from the breakdown of polymer-based device materials, which are evaluated for their potential biological effects.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Preliminary Hazard Analysis (PHA): Brainstorming structured process to identify hazards and hazardous situations early in medical device development.
Pre-market Approval (PMA): The process by which the U.S. FDA evaluates and approves the safety and effectiveness of high-risk medical devices before they can be marketed and sold in the United States.
Probability of Occurrence: The likelihood that a specific hazard will occur.
Process Controls: The tools and methods to monitor and manage medical device manufacturing processes.
Process Performance Qualification (PPQ) Studies:
• Installation Qualification (IQ): Verifying that equipment and installations meet the required specifications.
• Operational Qualification (OQ): Confirming that equipment and processes operate correctly under defined conditions.
• Performance Qualification (PQ): Demonstrating that processes perform effectively and reproducibly in real-world conditions.
Priority Medical Device: A technology identified by health authorities as critical for addressing public health needs and may receive expedited regulatory processes or funding support.
Process Verification: Uses process controls to check individual manufacturing steps and components against specifications.
Process Validation: Ensures that the entire manufacturing process, supported by process controls, reliably produces products meeting all requirements.
Procurement: The process of acquiring, purchasing, or obtaining medical equipment, supplies, or technology necessary for healthcare delivery.
Q
Qualification: The process of determining whether a product meets the definition of a medical device in a particular jurisdiction.
Quality: The degree to which a device consistently meets regulatory requirements and user expectations for safety, efficacy, reliability, and performance.
Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.
Quality Controls: The measures and tests conducted on the final product or at the end of the production process to ensure it meets all specified quality standards and regulatory requirements.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Quality Manual (QM): The highest-level document in the QMS hierarchy, containing the QMS scope, structure, and process map. This document may be a single document or a series of related documents.
The Quality Manual may also be known as the Quality Management Manual (QMM).
Quality Policy: a formal statement of the organisation’s commitment to quality, regulatory compliance, and continuous improvement.
Quality Objectives: specific, measurable goals aligned with the quality policy. Objectives help drive improvement and ensure alignment with organisational goals.
RReal World Evidence: Clinical evidence regarding the use and potential benefits or risks of a medical product derived from real-world data (RWD) sources outside traditional clinical trials.
Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Affairs (RA): A profession within regulated industries, such as pharmaceuticals and medical devices, which ensures that companies comply with all of the regulations and laws pertaining to their business.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Residual Risk: The risk remaining after risk control measures have been taken.
Risk: The combination of the probability of occurrence of harm and the severity of that harm.
Risk Analysis: The systematic use of available information to identify hazards and to estimate the risk.
Risk Assessment: The overall process comprising risk analysis and risk evaluation.
Risk Communication: The exchange of information about risks between decision-makers and other stakeholders.
Risk Control: The process by which decisions are made, and measures are implemented to reduce or maintain risks within specified levels. It is also known as Risk Mitigation.
Risk Evaluation: The process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Risk Management Plan (RMP): A document that outlines the risk management process for a medical device throughout its lifecycle.
Risk Management File (RMF): A compilation of all documents and records generated during the risk management process.
Risk Management Report (RMR): A summary of the risk management activities and outcomes, including overall residual risk acceptability.
SSafety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Sales Channel: A pathway or route through which a company sells its products or services to customers, encompassing direct and indirect methods such as retail, e-commerce, distributors, and wholesalers.
Sensitivity Analysis: The process of evaluating how the variation in the output of a model can be attributed to different variations in the input parameters.
Severity: A measure of the possible consequences of a hazard. Also see Risk and Probability of Occurrence.
Sponsor: An individual, company, institution, or organisation that takes responsibility for the initiation, management, or financing of a clinical investigation.
Stakeholder: Any individual or group with an interest or influence in the delivery, outcomes, or policies of healthcare services.
Standard: A document that provides guidance, requirements, or specifications established by regulatory
bodies, industry organisations, or international consensus groups.
Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity in the performance of a specific function.
Sterilisation: A process designed to destroy all microbial life, including spores, on a medical device.
Stringent Regulatory Authority (SRA): An established governmental agency or body that rigorously evaluates and monitors the safety, efficacy, and quality of medical devices through comprehensive regulatory frameworks and standards. Also see Regulatory Authority.
Study Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
Subject: An individual who participates in a clinical study, either as a recipient of the investigational device or as a control.
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices (STED): A document format and template developed by the Global Harmonization Task Force (GHTF)
Summative Evaluation: The final usability testing process that validates the effectiveness, efficiency, and satisfaction of the user interface before market release. Also, see Usability Testing.
Supplier: An entity or organisation that provides materials, components, or finished products used in the manufacturing, assembly, or distribution of medical devices.
Supplier Management: Overseeing and controlling the relationships and activities with external suppliers to ensure the quality, reliability, and regulatory compliance of sourced materials and components.
Supply Chain: Activities, processes, and entities involved in the sourcing, manufacturing, distribution, and logistics management of these devices from suppliers to end-users.
Systematic Review: A structured and comprehensive synthesis of research studies that aims to identify, select, assess, and summarise the findings of all relevant individual studies on a particular topic.
TTask Analysis: The process of breaking down tasks into smaller components to understand the steps involved, the interactions required, and potential errors.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Technical Specifications: Detailed descriptions of the requirements, characteristics, and standards that a product, service, or system must meet or adhere to, ensuring clarity and consistency in its design, production, or implementation. Also see Standard. Technical specifications can also be an alternative term for Design Inputs.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
Traceability Matrix: A document that maps and links requirements throughout the development lifecycle, ensuring that each requirement is tested and validated, thereby demonstrating compliance with regulatory standards.
UUnique Device Identification (UDI): A system that marks and identifies medical devices within the healthcare supply chain.
Universal Health Coverage (UHC): Ensuring all individuals and communities receive the necessary health services without suffering financial hardship.
Usability Engineering: The process of designing medical devices to ensure they are safe, effective, and easy to use by intended users under specified conditions.
Usability Testing: The evaluation of a medical device by testing it with real users to identify usability issues and improve the design.
Use Environment: The settings and conditions under which a medical device is used, such as hospitals, clinics, or home settings.
Use Error: Errors that occur during the use of a device due to poor design, leading to incorrect operation by the user.
Use Scenario: A detailed narrative describing the sequence of actions that a user would take to complete a task with the medical device in a specific context.
User-Centred Design (UCD): An iterative design process in which the needs, preferences, and limitations of end-users are given extensive attention at each stage of the design process.
User Profile: A detailed description of the intended users of the medical device, including their
demographics, experience, and skills. Also known as a User Persona.
User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.
Validation: Confirmation by examining and providing objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
Verification: The process of evaluating whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition.
Vigilance: The systematic process of monitoring, evaluating, and responding to safety issues and adverse events related to medical devices to ensure ongoing safety and compliance with regulatory standards.
Withdrawals: Participants who leave a study before its completion
World Health Organisation (WHO): A specialised agency of the United Nations responsible for international public health.
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