A Guide to Medical Device Terminology

The medical device industry can be intricate and overwhelming, with many technical terms and critical steps along the way. At Nova, we support our clients through every phase, offering expert guidance and education to ensure you’re informed at every turn. To help you navigate this landscape, we’ve created a comprehensive glossary of key terms and phrases you’re likely to encounter on your medical device journey. Enter your email to receive our downloadable guide, so you’ll always have a helpful resource at your fingertips when you need a quick refresher.

FDA (Food and Drug Administration):

Is a regulatory agency of the United States Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of food products, pharmaceuticals, medical devices, cosmetics, and other related products.

ISO (International Organization for Standardization):

Is an independent international body that develops and publishes standards to ensure quality, safety, and efficiency across various industries. These standards facilitate international trade and promote best practices, including in the healthcare sector for medical devices and quality management systems.

SOP (Standard Operating Procedure):

Is a documented set of step-by-step instructions that outline how to perform specific tasks or processes consistently within an organization. SOPs are designed to ensure compliance with regulatory requirements, maintain quality standards, and promote efficient and effective operations by providing clear guidelines for employees to follow.

Medical Device:

Is any instrument, apparatus, machine, implant, or similar article used for diagnosing, preventing, treating, or monitoring diseases or medical conditions. Medical devices achieve their intended purpose through physical or mechanical means rather than chemical or biological actions. Examples include items like pacemakers, syringes, MRI machines, and even simple tools like thermometers and bandages. Medical devices are regulated to ensure their safety and effectiveness for patient care.

Medical Device Classification:

Is a system used to categorize medical devices based on their level of risk to patients and users. In the U.S., the FDA classifies devices into three category classes.

Class I Medical Device:

Is a category of medical devices that are considered to have the lowest risk to patients and users. These devices are subject to general controls to ensure their safety and effectiveness, which may include regulations related to manufacturing, labeling, and reporting adverse events. Examples of Class I devices include items such as bandages, examination gloves, and handheld surgical instruments. Most Class I devices do not require premarket approval or a 510(k) submission, but they must comply with the applicable regulatory standards set by the FDA.

Class II Medical Device:

Is a category of medical devices that pose a moderate risk to patients and users. These devices require both general controls and specific controls to ensure their safety and effectiveness. Class II devices typically necessitate a premarket notification, known as a 510(k) submission, which demonstrates that the device is substantially equivalent to a legally marketed device. Examples of Class II devices include infusion pumps, surgical drapes, and powered wheelchairs. The regulatory framework for Class II devices aims to provide additional assurance of safety and effectiveness through performance standards and post-market surveillance.

Class III Medical Device:

Is a category of medical devices that pose the highest risk to patients and users. These devices are typically used to support or sustain life, prevent impairment, or present a potential unreasonable risk of illness or injury. Class III devices require rigorous regulatory controls, including premarket approval (PMA) from the FDA, which involves providing extensive clinical data to demonstrate the device's safety and effectiveness. Examples of Class 3 devices include implantable pacemakers, artificial hearts, and some high-risk diagnostic tests. The stringent regulatory requirements for Class III devices ensure thorough evaluation before they can be marketed.

SaMD (Software as a Medical Device):

Refers to software that is intended for medical purposes and is used for diagnosis, prevention, monitoring, or treatment of diseases without being part of a hardware medical device. SaMD must comply with regulatory standards and guidelines to ensure safety and effectiveness, similar to traditional medical devices.

510(k) Submission:

Is a premarket notification filed with the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed device that is not subject to premarket approval (PMA). The 510(k) process requires the manufacturer to provide data and information that establish the safety and effectiveness of the device, including comparisons to the predicate device in terms of intended use, design, and performance. Once the FDA issues an order that finds the device to be substantially equivalent (SE), the device may be legally marketed in the U.S. This order "clears" the device for commercial distribution.

Substantially equivalent (SE):

Means that a new device is comparable in intended use and safety to an already FDA-approved device, known as a predicate device. For a device to be cleared through the FDA’s 510(k) process, it must demonstrate that any technological differences do not raise new safety or efficacy concerns. This designation allows the device to bypass the more extensive premarket approval (PMA) process.

De Novo:

Refers to an FDA regulatory pathway for the classification and approval of new medical devices that are considered low to moderate risk but do not have a legally marketed predicate device. This process allows manufacturers to submit a De Novo request to establish a new device classification, providing a streamlined route to market for innovative products while ensuring safety and effectiveness.

Human Factors Engineering (HFE)

Focuses on optimizing the interaction between people and systems to improve usability, safety, and performance. In medical devices, HFE ensures designs minimize user errors and align with human capabilities.

Task Analysis:

Is the systematic process of breaking down and examining how users perform tasks within a system, product, or environment. This analysis helps uncover potential challenges, inefficiencies, or safety concerns, guiding improvements in design and usability.

IRB (Institutional Review Board):

Is a committee established to review and oversee research involving human subjects, ensuring that ethical standards are upheld and that participants' rights and welfare are protected. The IRB evaluates research proposals to assess risks, benefits, and informed consent processes, ensuring compliance with federal regulations and institutional policies.

Formative Study:

Is an early-stage evaluation used to gather feedback on the design and usability of a product or system, such as a medical device. It involves testing prototypes with real users to identify potential issues, improve design, and ensure the product meets user needs before finalization.

Summative Study:

Is a final evaluation conducted to validate that a product or system, such as a medical device, meets usability and safety requirements associated with usability. It involves testing the commercially representative design with representative users under realistic conditions to ensure it can be used safely and effectively. Summative studies are often required for regulatory approval, as they confirm that user needs and risk mitigation have been adequately addressed.

User Group:

Refers to a specific set of individuals who will interact with a product, system, or device, sharing similar characteristics or needs. Understanding the user group is crucial for designing products that meet their needs, capabilities, and limitations, ensuring safety and effectiveness.

Context of Use:

Refers to the specific conditions and environments in which a product or system is intended to be used, including the users, their tasks, and the surrounding circumstances. Understanding the context of use is essential for designing effective and user-friendly products that meet the needs of the target audience.

Intended Use:

Is the general purpose of the device or its function.  This includes the indications for use.

Indications for Use:

Describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

Use Error:

Refers to mistakes made by users while interacting with a product, system, or device, often leading to unintended outcomes or hazards.

Error Mode:

Refers to the specific ways in which a user might incorrectly operate a system or device, leading to unintended outcomes or failures. In the context of human factors engineering and risk analysis, identifying error modes helps in understanding potential user mistakes and designing systems that minimize the likelihood of such errors, thereby enhancing safety and usability.

Accessibility:

Refers to the design and development of products, systems, or environments that are usable by people with a wide range of abilities and disabilities. This involves implementing features like clear labeling, adaptable interfaces, and assistive technologies to create an inclusive user experience.

Usability:

Refers to the ease with which users can interact with a product, system, or device to achieve their goals effectively and efficiently. 

Human Reliability:

Refers to the likelihood that a human operator will perform a task accurately and consistently, particularly in high-stakes environments such as healthcare or manufacturing. Understanding and enhancing human reliability involves analyzing factors that influence performance, such as training, workload, and environmental conditions, to reduce errors and improve safety.

Heuristic Evaluation:

Is a usability inspection method used to identify usability issues in a user interface by evaluating it against established usability principles, or heuristics. During this process, a small group of evaluators assesses the interface independently, checking for problems that could hinder user experience and effectiveness.

Workload Assessment:

Is the process of evaluating the demands placed on individuals or teams during tasks or operations to determine whether the workload is manageable and appropriate. This assessment helps identify potential issues related to fatigue, performance, and safety, allowing for adjustments to optimize efficiency and well-being.

Anthropometry:

Is the scientific study of human body measurements, including dimensions, proportions, and physical characteristics. In the context of design and ergonomics, such as in medical devices, anthropometry is used to ensure that products are tailored to fit the diverse range of users, enhancing comfort, usability, and safety

Ergonomics:

Is the science of designing products, systems, and environments to optimize human well-being and overall system performance. It involves understanding human capabilities and limitations to enhance comfort, safety, and efficiency in interactions with technology and physical spaces.

Cognitive Ergonomics:

Focuses on optimizing the interaction between human cognitive abilities and system design. It addresses how users process information, make decisions, and perform tasks, considering factors like memory, attention, perception, and problem-solving.

Cognitive Load:

Refers to the mental effort required to process information and complete tasks. It encompasses the total amount of working memory used during an activity, which can impact learning, decision-making, and performance.

Human-Machine Interaction:

Refers to the study and design of the interactions between humans and machines or systems, focusing on how users operate and communicate with technology. This field encompasses aspects of usability, ergonomics, and cognitive psychology to optimize the user experience, enhance safety, and improve performance in various applications, including medical devices, automation, and consumer products.

Human-System Interface:

Refers to the point of interaction between users and complex systems, including both hardware and software components. It encompasses the design and layout of controls, displays, and feedback mechanisms that facilitate effective communication and operation between humans and the system, aiming to enhance usability, efficiency, and overall user experience. In contexts like medical devices, a well-designed human-system interface is crucial for ensuring safety and effectiveness.

HCI (Human-Computer Interaction):

Is the multidisciplinary field that studies the design, evaluation, and implementation of interactive computing systems for human use. It focuses on understanding how people interact with computers and technology, aiming to improve usability, accessibility, and overall user experience through principles of design, psychology, and ergonomics. HCI encompasses various applications, including software interfaces, web design, and the development of new interaction techniques.

FMEA (Failure Modes and Effects Analysis):

Is a systematic, proactive method used to identify potential failure modes within a product or process, assess their impact on performance and safety, and prioritize them based on their severity, occurrence, and detectability. This analysis helps teams develop strategies to mitigate risks and improve design or process reliability, ultimately enhancing product quality and safety.

UFMEA (User Failure Modes and Effects Analysis):

Is a systematic method used to identify and evaluate potential user-related errors in the operation of a product or system, particularly in medical devices. This analysis focuses on understanding how users might misuse or misunderstand the device, the potential consequences of these errors, and the likelihood of their occurrence.

Life Cycle Analysis:

Is a systematic evaluation of the environmental impacts associated with all stages of a product's life, from raw material extraction through production, use, and disposal. LCA helps identify opportunities for reducing environmental harm and improving sustainability throughout the product's life cycle.

Usability Engineering File (UEF):

Is a documented collection of all usability engineering activities conducted during the development of a medical device, including user requirements, testing protocols, and results. It demonstrates compliance with regulatory standards and ensures that the device is designed to meet the needs of its users effectively.

Design History File:

Is a comprehensive collection of documents that record the design and development process of a medical device. It includes all relevant information generated throughout the design lifecycle, such as design plans, design inputs and outputs, verification and validation activities, design changes, and risk assessments.  

Device Master Record (DMR):

Is a comprehensive collection of documents that includes the specifications, manufacturing processes, quality assurance procedures, and labeling for a medical device. It serves as the official record that outlines how the device is produced and ensures compliance with regulatory requirements throughout its lifecycle.

Design Controls:

Are a set of systematic processes and procedures implemented during the development of a medical device to ensure that it meets user needs and regulatory requirements. These controls include planning, design verification and validation, documentation, and risk management activities throughout the product lifecycle. 

Design Verification:

Is the process of confirming that a medical device or product meets its specified design requirements and specifications during development. It involves systematic testing and analysis to ensure that the design outputs align with the design inputs, thereby demonstrating that the product has been built correctly.  

Design Validation:

Is the process of evaluating a medical device or product to ensure that it meets the user needs and intended uses in real-world conditions. It involves testing and assessing the final product against predefined criteria to confirm that it performs as expected and is safe for users.

Root Cause Analysis:

Is a systematic approach used to identify the fundamental underlying reasons for a problem or adverse event. By determining the root causes, organizations can implement effective solutions to prevent recurrence and improve processes or systems.

Risk Control:

Refers to the process of implementing measures to reduce, eliminate, or manage identified risks associated with a product, process, or system to specified level. In the context of medical devices, risk control involves applying strategies such as design modifications, warnings, or training to minimize the likelihood and impact of adverse events, ensuring patient safety and regulatory compliance. 

Risk Management:

Is the process of identifying, assessing, prioritizing, controlling, and monitoring potential risks associated with a product, system, or process. In medical device development, it involves evaluating the likelihood and impact of hazards that could cause harm to users or patients. The goal is to implement measures to minimize or mitigate these risks, ensuring the device’s safety and regulatory compliance.

QA (Quality Assurance):

Is a systematic process that ensures products and services meet specified quality standards and regulatory requirements through planned and systematic activities. QA focuses on preventing defects and improving processes to enhance overall quality and customer satisfaction.

QC (Quality Control):

Is a process used to monitor and evaluate the quality of a product or service through inspection, testing, and measurement. It aims to identify defects or variations from specifications during production, ensuring that the final output meets the required standards and customer expectations.

QMS (Quality Management System):

Is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives within an organization. In the context of medical devices, a QMS ensures that products consistently meet regulatory requirements and customer expectations through systematic processes for quality planning, control, assurance, and improvement.

Post-Market Surveillance:

Refers to the systematic monitoring and evaluation of a medical device's performance and safety after it has been marketed and used in the general population. This process helps identify any adverse effects, assess long-term safety, and ensure ongoing compliance with regulatory requirements.

Medical Device Reporting (MDR):

Is a regulatory requirement that mandates manufacturers, importers, and healthcare facilities to report adverse events and product defects related to medical devices to the FDA. This process helps ensure patient safety by facilitating the identification of potential safety issues and allowing for timely corrective actions.