Clear definitions for the terms people encounter while choosing systems, reviewing records, and using AI at work.
107 terms
21 CFR Part 820 sets forth the current good manufacturing practice (CGMP) requirements for finished medical devices intended for human use. These requirements govern the methods, facilities, and controls used for the entire device lifecycle, including design, manufacture, packaging, labeling, storag
Read the definitionThe 510(k) submission, formally known as Premarket Notification , is an application submitted to the Food and Drug Administration (FDA). In simple terms, the 510(k) submission is the process by which medical device manufacturers demonstrate that their new device is substantially equivalent (as safe
Read the definitionAn Accreditation Body is an entity, usually a private nonprofit organization or a state agency, that is officially approved by a regulatory authority, such as the FDA, to evaluate and certify facilities or organizations for compliance with established quality or safety standards. In simple terms, th
Read the definitionAI Management, as represented by the ISO 42001 standard, refers to the systematic approach for managing and controlling activities related to Artificial Intelligence within an organization. Management systems typically provide a comprehensive framework of processes, procedures, and responsibilities
Read the definitionThe AS9100 standard, often referred to as the Aerospace Basic Quality System Standard, is essentially the version of the international quality standard (ISO 9001) that has been tailored specifically for the aviation, space, and defense industry (the aerospace sector) The ISO 9001 standard provides a
Read the definitionThe Change Assessment process (often referred to as Change Control or Change Management ) is the formal evaluation undertaken by an organization to determine the impact of any proposed modification to its products, documentation, procedures, facilities, or quality systems. A Change Assessment is the
Read the definitionThe Change Control Process (or Change Management/Change Control System) is the systematic, mandatory mechanism used by organizations, particularly those in regulated industries like medical device manufacturing, to manage, review, approve, document, and implement any planned modifications to product
Read the definitionChange Management refers to the overall strategy and comprehensive effort an organization undertakes to ensure that any modification to a process, product, document, or system is implemented effectively, safely, and without unintended adverse consequences, while maintaining compliance. Change Manage
Read the definitionA compilation of documentation for a change, which includes detailed explanations from the assessment of scope, impact, associated risks, tasks, and actions to be taken, along with supporting evidence. This packet needs to be reviewed and approved by every involved department. A Change Packet is the
Read the definitionThe term Complaint, as it relates to medical devices, refers to any formal communication alleging a deficiency related to a device after it has been released for distribution. The handling of complaints is a mandatory and critical process within a medical device manufacturer’s Quality Management Sys
Read the definitionThe practice of embedding improvement into the QMS as a permanent objective, often driven by models like the Plan-Do-Check-Act (PDCA) cycle. It involves tracking customer satisfaction and is required by ISO 9001 . In simple terms, continual improvement is the ongoing, structured effort to enhance pr
Read the definitionCorrective Action is the fix that prevents the same mistake from happening twice . It is the "Corrective" part of the comprehensive Corrective and Preventive Action (CAPA) process. The term Corrective Action (CA) refers specifically to the actions taken within a formal quality system to eliminate th
Read the definitionThe term CAPA , which stands for Corrective and Preventive Action , refers to a fundamental and mandatory system within a Quality Management System (QMS) designed to ensure product safety, quality, and regulatory compliance, particularly within the medical device industry. In simple terms, CAPA is t
Read the definitionRegulations covering manufacturing processes, including those for combination products, to ensure product quality. cGMP ensures that products are consistently manufactured and controlled in accordance with quality standards appropriate to their intended use. For medical devices, failure to comply wi
Read the definitionCustomer Focus, as a core concept in quality management, is formally recognized as one of the seven quality management principles (QMPs) that form the foundation of the ISO 9000 series of international standards. Here are other essential things you need to know about Customer Focus, particularly in
Read the definitionDesign Changes (21 CFR 820.30(i)) is a crucial part of the FDA's Quality System Regulation (QSR) for medical devices, specifically focusing on how manufacturers must control alterations to a device design once it is established. The regulation, 21 CFR 820 .30(i) Design changes , defines the strict p
Read the definitionThe concept of Design Controls is a mandatory system of procedures required for medical device manufacturers under the U.S. FDA's Quality System Regulation (QSR), specifically defined in 21 CFR Part 820, Subpart C (§ 820.30) . Design Controls are defined as a set of quality practices and procedures
Read the definitionDesign History File (DHF) is a compilation of records that describes the design history of a finished device . The Design History File (DHF) is a core requirement under the U.S. FDA’s Quality System Regulation (QSR) for medical device manufacturers, specifically detailed in 21 CFR 820.30(j) . Purpos
Read the definitionThe final, approved blueprints and instructions that tell the factory exactly how to build the product. Design Output is one of the mandatory elements of Design Controls under the U.S. FDA's Quality System Regulation (QSR) for medical device manufacturers, specifically outlined in 21 CFR 820.30(d) .
Read the definitionDesign Review is a mandatory, formal meeting held by the device manufacturer throughout the development process to stop, inspect, and critique the device design Design Review is a critical, mandatory checkpoint in the medical device development process, defined in the Quality System Regulation (QSR)
Read the definition Design Validation (21 CFR 820.30(g)) is the final and most important step in the design control process. It confirms that the completed device design works correctly for the people who will actually use it. In the simplest terms, Design Validation answers the ultimate question: "Did I make the cor
Read the definition Design Verification is the process of confirming, through evidence, that the device design created matches the technical specifications initially written . Design Verification is a crucial activity within the Design Controls framework (21 CFR 820.30(f)) for medical device manufacturers, serving as
Read the definitionThe DHR is the "birth certificate" or manufacturing log for every specific batch, lot, or individual unit of a device. It answers the question: "Was this specific device built correctly, according to the official instructions?" The Device History Record (DHR) ( 21 CFR 820 .184) is a mandatory qualit
Read the definitionThe Device Master Record (DMR) is the complete set of instructions and specifications necessary to produce, inspect, package, and service a specific type of finished device. It is the definitive guide for manufacturing operations. The Device Master Record (DMR) is a fundamental quality record requir
Read the definitionDocument Changes (21 CFR 820.40(b)) is the required procedure to ensure that when any official quality or manufacturing document (like a procedure, specification, or drawing) needs to be updated, the change is properly reviewed, approved by the right people, and communicated quickly throughout the f
Read the definition Document Control is the quality system process that ensures that every employee working on a device has access to the correct, current, and approved instructions needed to perform their job, and that old, incorrect instructions are immediately removed from use. The Document Controls section of the
Read the definition Documented Information refers generally to the required documents and records that must be established, maintained, and controlled within a formal quality management system (QMS) or regulatory compliance framework. In systems governed by standards like ISO 9001 :2015 or U.S. FDA regulations (such
Read the definitionThe EU Medical Device Regulation (EU MDR) , officially known as EU Regulation 2017/745 , is the primary regulatory framework governing the safety, performance, and market approval of medical devices within the European Union (EU) and the European Economic Area (EEA). Here is a comprehensive overview
Read the definition EUDAMED is the European database established for medical devices, playing a key role in compliance with the European Union's regulatory frameworks, specifically the Medical Device Regulation (EU MDR). The requirement to register in EUDAMED is a critical step in the MDD to MDR transition process ,
Read the definition Failure Mode and Effects Analysis (FMEA) is an organized way to predict and analyze every possible way a product, process, or system could fail, before it actually happens. The Failure Mode and Effects Analysis (FMEA) is a fundamental analytical tool used in quality management, particularly within
Read the definition Form, Fit, and Function (FFF) is a framework used in engineering, manufacturing, and product design to describe the essential characteristics of a component, part, or assembly that determine its compatibility, interchangeability, and performance within a system. It ensures that revisions or substi
Read the definitionThe concept of harm in process risk assessment (such as analysis using FMEA or other risk management tools) refers to the negative consequences or undesirable outcomes that result from a failure or hazardous situation. In the context of medical device quality systems , harm is typically defined by t
Read the definitionA hazard is simply defined as a "potential source of harm" . More broadly, a hazard is a designation of something that causes harm . For a hazard to cause harm, there must be a trigger event or a series of events, referred to as the hazardous situation . For example, bacterial contamination is consi
Read the definitionA hazardous situation is defined as the trigger event or series of events that must occur for a hazard (a potential source of harm) to actually cause harm. The term " hazardous situation " is central to the risk management framework, particularly under ISO 14971 for medical devices, which defines th
Read the definition Human Factors are defined as the study of the interactions between humans and the device (i.e., interface) and the subsequent design of the device-human interface . The concepts of Human Factors (HF) and Usability Engineering (UE) are critical, mandatory components of the Design Controls and risk
Read the definition IATF 16949 defines the Quality Management System (QMS) standards specifically for the Automotive industry . It is specified by The International Automotive Task Force (IATF). IATF 16949 is a sector-specific quality management standard for the automotive industry, building on the requirements of IS
Read the definitionThe EU IVDR (In Vitro Diagnostic Medical Devices Regulation) , officially known as EU Regulation 2017/746 , is the regulatory framework governing in vitro diagnostic (IVD) medical devices within the European Union (EU). Governing Scope: The EU IVDR (EU Regulation 2017/746) specifically governs in vi
Read the definitionIndustrial CT scanning is an advanced, non-destructive inspection method that uses X-rays and specialized reconstruction techniques to provide intricate 3D visualizations of internal structures of a product. Industrial CT (Computed Tomography) Scanning is a critical, advanced inspection technique us
Read the definitionAn Information Security Management System (ISMS) is a formal framework of policies, procedures, and controls based on the ISO 27001 standard that helps an organization manage and protect the confidentiality, integrity, and availability of its data and information assets. ISMS is a formal system base
Read the definition Interested Parties (or stakeholders ) are individuals or organizations that are relevant to the quality management system and whose needs and expectations the organization must determine, monitor, and review. The concept of Interested Parties is a fundamental component of the Quality Management Sy
Read the definitionAn internal audit is a systematic, independent examination of an organization's quality system or processes that is performed at defined intervals and sufficient frequency to determine whether its activities and results comply with established procedures and are effectively achieving quality system
Read the definitionAn Internal Audit Program is the comprehensive plan or system established by an organization, typically under Clause 9.2 of ISO 9001 , to carry out Internal Audits . It defines the necessary elements - including frequency, methods, responsibilities, planning requirements, and reporting - required to
Read the definitionThe Internet of Things (IoT) refers to advanced technology that can be integrated into Quality Management Systems (QMS) and other systems. Specifically, IoT sensors are recognized as providing continuous, real-time data on process parameters . The goal of integrating this technology is to facilitate
Read the definition ISO 9001 is the international standard that defines the requirements for an effective Quality Management System (QMS) . It is the specific standard within the ISO 9000 family to which an organization's QMS can be certified. Organizations certified to ISO 9001 demonstrate their ability to consisten
Read the definitionI SO 13485 is the international standard that defines the requirements for a Quality Management System (QMS) specifically for medical devices . It is known as the medical industry's equivalent of ISO 9001. The standard places particular emphasis on management reviews, process and design control in m
Read the definition ISO 14971 is the international standard that defines the requirements and processes for applying risk management to medical devices . The International Organization for Standardization (ISO) standard ISO 14971 is the definitive standard for applying risk management specifically within the medical
Read the definition ISO 17025:2017 is a quality management system (QMS ) standard that is applicable only to Testing and Calibration Laboratories . It specifies the general requirements for the competence, impartiality, and consistent operation of these laboratories. The ISO standard ISO/IEC 17025 is a specific, sect
Read the definition ISO 27001 is the Information Security Management System (ISMS) standard that outlines the requirements for protecting an organization's sensitive data. Its primary goal is to help an organization manage and protect the confidentiality, integrity, and availability of its information assets. Achievi
Read the definition ISO 27701 defines the requirements for a Privacy Information Management System (PIMS) . It is designed to help organizations manage and protect Personally Identifiable Information (PII) . The ISO standard ISO/IEC 27701 is a specialized extension of the information security standard (ISO 27001), fo
Read the definition Lean Manufacturing (or Lean principles ) is a management methodology that focuses on eliminating waste and improving flow in processes . It is an advanced approach in quality management that integrates with QMS frameworks. The concepts of Lean Manufacturing and Lean principles are modern methodolo
Read the definitionA "letter to file" (LTF) is internal documentation used by medical device companies to record a change to an already FDA-cleared device when that change does not require a new regulatory submission The function of a Letter to File is a documented statement or record, internal to the organization or
Read the definitionMachine Learning (ML) is as an advanced methodology, often paired with Artificial Intelligence (AI) , used in Quality Management Systems (QMS) and digital devices to analyze large datasets and predict potential quality issues . Machine Learning (ML) is being integrated into Quality Management System
Read the definitionManagement Review is a formal procedure in which the highest levels of leadership (often referred to as management with executive responsibility ) periodically review the overall performance of the organization’s Quality Management System (QMS) . In essence, it is a mandated meeting or process desig
Read the definitionA Mechanical Failure is the inability of a device or component to withstand the physical forces and conditions it is designed for, often resulting in structural weaknesses, broken parts, or a breakdown in intended function. In regulatory terms, this often translates to a Malfunction , which is defin
Read the definitionA Medical Device Quality Management System (MDQMS) is a comprehensive organizational framework of processes, procedures, responsibilities, and resources established to guarantee that all medical devices meet predetermined quality standards, statutory, and regulatory requirements MDQMS is a highly re
Read the definition NIS 2 (Network and Information Systems Directive 2) is the European Union's cybersecurity directive designed to increase the overall resilience and responsiveness of organizations operating critical infrastructure. The term NIS 2 refers to a major regulatory effort by the European Union focused on
Read the definitionA Nonconformity (or Nonconformance) is defined as the non-fulfillment of a specified requirement . The concept of Nonconformances is central to quality management , as it represents a failure within the Quality Management System (QMS) that must be identified, contained, assessed, and ultimately corr
Read the definition A Nonconformity (or Nonconformance) is the non-fulfillment of a specified requirement . In simple terms, a nonconformity is a failure of any product, process, service, or system activity to meet a predefined rule, specification, or expectation. These issues may be referred to broadly as quality pr
Read the definition Nonconformity Management refers to the comprehensive, structured process required within a Modern Quality Management System (QMS) to handle instances where requirements are not met. This process is mandatory across international standards like ISO 9001 and specific regulatory frameworks like the F
Read the definition A Notified Body is specific to the European regulatory environment, particularly for medical devices, and is a mandated, independent third-party assessment required for market access. A Notified Body is an EU-authorised organisation responsible for independently evaluating whether a manufacturer's
Read the definitionA Post-Market Approval (PMA) Supplement is a regulatory mechanism specific to the U.S. Food and Drug Administration (FDA) and is exclusively associated with major, high-risk medical devices that have already received primary FDA clearance. In simple terms, a PMA Supplement is a formal supplemental a
Read the definition Post-Market Changes are any modifications made to a medical device, its components, its manufacturing processes, its labeling, or its associated quality systems after the device has achieved regulatory clearance or approval and is in commercial distribution. These changes are highly regulated, esp
Read the definition Post-Market Surveillance (PMS) refers to the active, systematic, and continuous monitoring of a medical device's performance, safety, and effectiveness after it has been commercially distributed. It is a mandatory regulatory requirement, especially for devices marketed in the United States (under
Read the definition Pre-Market Changes are modifications, adjustments, or revisions made to a medical device, its intended use, or its documentation during the critical stages before it is legally introduced into commercial distribution, requiring formal regulatory submission and internal design control procedures. I
Read the definition Predictive Risk Management (PRM) is a forward-looking, data-intensive approach to quality and safety that leverages advanced data analysis to anticipate and mitigate potential failures or adverse events before they materialize. Predictive Risk Management is the QMS process of using big data, machi
Read the definitionThe term Premarket Approval (PMA) refers to the most stringent regulatory pathway required by the U.S. Food and Drug Administration (FDA) for marketing medical devices. In simple terms, a Premarket Approval (PMA) is the formal regulatory application submitted to the FDA for a Class III medical devic
Read the definitionThe Premarket Notification (510(k)) is the primary regulatory pathway used by the U.S. Food and Drug Administration (FDA) to market most Class I and Class II medical devices . Unlike the Premarket Approval (PMA) process, which requires proof of safety and effectiveness, the 510(k) pathway focuses on
Read the definitionThe term Preventive Action (PA) is a fundamental, forward-looking component of a Quality Management System (QMS) and is explicitly mandated by regulatory standards globally, especially in the medical device industry. PA operates proactively, focusing on avoiding potential issues rather than fixing e
Read the definitionThe term Privacy Information Management System (PIMS) refers to a specific type of management system designed to govern the collection, use, protection, and disposal of Personally Identifiable Information (PII) within an organization. It is typically implemented in compliance with the ISO/IEC 27701
Read the definitionThe Process Approach is a foundational principle of modern Quality Management Systems (QMS), particularly those based on the ISO 9000 family of standards . It is a strategic way of managing an organization by viewing its activities as a system of inter-related processes, rather than as separate depa
Read the definition Process Risk Assessment (PRA) is the methodology used within a Quality Management System (QMS) to systematically identify, analyze, evaluate, and control potential risks and opportunities associated with the operational processes (activities, methods, or procedures) required to deliver a product o
Read the definitionThe term Process Validation refers to the requirement in medical device manufacturing (and related life science industries) to establish, through objective evidence, that a manufacturing process will consistently produce results or products that meet their predetermined specifications [59(1), 300(kk
Read the definitionA Quality Event is any occurrence that involves the quality, performance, or conformity of a product, process, or system (planned or unplanned). In regulatory and medical device contexts, "quality event" is often used synonymously with an issue that triggers investigation and action within the Quali
Read the definitionThe term Quality Management refers to the comprehensive process, functions, and underlying intentions established by an organization to ensure that its products and services consistently meet established standards, customer requirements, and regulatory criteria. Quality Management is the strategic f
Read the definition A Quality Management System (QMS) is a formalized, organized framework that establishes and maintains policies, procedures, resources, and responsibilities to consistently achieve and manage quality objectives. A Quality Management System (QMS) is a structured framework of processes, procedures, a
Read the definitionThe Quality Management System Regulation (QMSR) is the updated set of current good manufacturing practice (CGMP) requirements for finished medical devices intended for human use. It was established by the FDA in 2024 to harmonize the former 1996 Quality System (QS) regulation (21 CFR Part 820) by in
Read the definitionThe Quality Manual is a foundational document within an organization's Quality Management System (QMS) and quality assurance departments , traditionally serving as the top-level document that outlines the system's structure and the organization's commitment to quality. A Quality Manual is a document
Read the definition Quality Objectives are specific, measurable goals established by an organization's top management to support its Quality Policy and drive the continual improvement of its Quality Management System (QMS). Quality Objectives are the defined, quantifiable targets an organization aims to achieve to de
Read the definition A Quality Policy is a document established by an organization's top management that sets forth the overall intentions and direction regarding quality . The Quality Policy is the formal, declarative statement of an organization's mission and commitment to quality . It serves as the primary guidance
Read the definition Quality Procedure (often simply referred to as a "Procedure") are a set of instructions that detail the necessary steps and activities to be followed in the execution of specific processes within a Quality Management System (QMS). A Quality Procedure is a controlled document that outlines who perf
Read the definition REACH Compliance is the mandatory conformance requirements concerning Restricted Materials/Substances within a product, particularly those governed by specific European Union regulations. REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals . REACH Compliance means
Read the definitionA Record is historical documentation retained to demonstrate that mandatory procedures have been followed, requirements have been met, and management objectives have been achieved, ensuring traceability and legal compliance. Forms are the blank templates filled in with information that become record
Read the definition Residual Risk is the leftover risk(the probability and severity of harm) that an organization cannot eliminate through design features, protective barriers, or labeling/training. This remaining risk must be evaluated against established acceptance criteria and typically requires a documented justi
Read the definition Return Material Authorization (RMA) is a formal, controlled process within a Quality Management System (QMS) that governs the return, evaluation, disposition, and corrective action for non-conforming, defective, damaged, or unwanted products from customers or downstream processes. Functionally, RM
Read the definition Risk Analysis is the structured activity of identifying hazards (potential sources of harm) and estimating the risk (combining the probability of harm occurring with the severity of that harm) before any mitigation efforts are formally applied. It is the first critical step in understanding the ri
Read the definitionRisk Control is the mandatory phase of risk management in which mitigation measures are identified, implemented, and verified to reduce the likelihood of harm occurring or its severity to meet predefined acceptability criteria. The term Risk Control refers to the actions, methods, and practices impl
Read the definition Risk Estimation is the systematic act of scoring a potential quality issue by assessing two primary factors: the severity of the possible resulting harm and the probability that the harm will occur. This process yields a measurable output, often referred to as a risk index , which represents the o
Read the definitionThe Risk Management File (RMF) is the central repository of evidence/complete audit trail that confirms hazards were identified, risks were evaluated, appropriate controls were implemented, and the remaining risk is acceptable. It contains the records for all things risk management . The RMF is a ma
Read the definition Risk-Based Thinking is the practice of embedding the principles of risk management into the entire Quality Management System (QMS) , ensuring that decisions are proactive and prioritize minimizing negative effects (risks) while maximizing desirable effects (opportunities). It functions as a preven
Read the definition RoHS Compliance refers to mandatory conformance with the Restriction of Hazardous Substances standards, which limit the use of specific regulated materials in manufactured products. RoHS compliance is a key requirement in the purchasing and supplier quality standards, particularly when dealing wit
Read the definition Root Cause Analysis (RCA) is the mandatory investigation conducted within a formalized process (like CAPA) to determine the underlying causes of a failure, nonconformity, or defect, rather than simply addressing the visible symptoms. The goal of RCA is to eliminate the actual source of the problem
Read the definition Six Sigma is an advanced methodology that focuses on quality improvement by using statistical tools to reduce variation in processes, thereby minimizing defects and nonconformities. When combined with Lean manufacturing principles, it creates Lean Six Sigma , which addresses both quality and effic
Read the definition Software as a Medical Device (SaMD) , or software regulated as a medical device, is software that functions as a device in its own right, separate from any physical hardware, or to software that is an integral, regulated component of a medical device system. SaMD is defined by its application: ISO
Read the definitionA Standard Operating Procedure (SOP) is the detailed, step-by-step documentation established by a manufacturer to define and control the manner of production and quality system processes. SOPs are crucial for ensuring consistency in process execution, reducing variation, and maintaining compliance,
Read the definitionA Supplier Corrective Action Request (SCAR) is a mandatory process initiated by a purchasing organization that requires a supplier to formally investigate and resolve deficiencies in the quality of the product or service provided. A Supplier Corrective Action Request (SCAR) is a documented demand fr
Read the definition TL 9000 is an industry-specific interpretation of the ISO 9001 standard for the telecommunications sector. TL 9000 is the Telecom Quality Management and Measurement System Standard . It is a specialized Quality Management System (QMS) standard, built upon the foundation of ISO 9001 , created speci
Read the definition Traceability in a QMS refers to the mandatory systems and records established to ensure that a product can be traced through every stage of its lifecycle, particularly by tracking a specific item or batch backward to its source or forward to its end-user. Traceability is the ability to follow the
Read the definitionA Traceability Matrix (or traceability analysis/documentation) is a structured mechanism, typically a key element of the Risk Management File, that links inputs, outputs, and corresponding activities throughout a controlled process, ensuring that every element of a product's design or identified haz
Read the definition Triggers for Change are specific events, findings, or deliberate decisions that initiate the formal investigation and structured management processes, such as the Corrective and Preventive Action (CAPA) system or Design Change Control, within a Quality Management System (QMS) . These triggers sign
Read the definition Vigilance Reporting is the mandatory systems and processes within a Quality Management System (QMS ) used to identify, document, and report serious adverse events, malfunctions, and corrective actions related to marketed medical devices to regulatory authorities. Vigilance Reporting is the systema
Read the definition Visual Inspection is a quality control technique used to physically examine products, components, or manufacturing materials for visible flaws or deviations from specified standards. Visual Inspection is a critical, mandated quality control process in which personnel systematically look for noncon
Read the definition Voice of the Customer (VOC) is a structured process in business and quality management for capturing, analyzing, and translating customers' needs, expectations, preferences, complaints, and feedback into actionable requirements. It treats the "customer" broadly, not just end users but also interna
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