Every industry has its own set of specialized jargon, and the medical field is no exception. Your understanding of medical device terminology enables you to work efficiently, communicate clearly, and minimize errors and misunderstandings when designing, developing, manufacturing, and selling medical devices.
　　It is well known that the medical device industry features a wealth of specialized terminology, much of which consists of English acronyms and abbreviations—terms that can sometimes be confusing for everyone. Below, we’ve compiled a list of commonly used medical device acronyms along with their definitions, making it easier for you to grasp the key concepts.
　　1) 21 CFR Part 820
　　The FDA maintains the Quality System Regulation, or QSR, outlined in Title 21, Part 820 of the Code of Federal Regulations, which sets forth quality system requirements for all medical device manufacturers in the United States. Under the provisions of 21 CFR Part 820, manufacturers are required to establish and maintain a quality system tailored to their medical devices, ensuring the safety and effectiveness of the products for their intended use.
　　2) CE Marking (CE MARKING/CE MARK)
　　Medical device manufacturers must obtain the CE marking or CE certification to distribute their products in the European Union (EU) market. The CE mark is issued by a third-party organization—known as a Notified Body—demonstrating compliance with the applicable EU medical device regulations.
　　3) European Committee for Standardization (CEN-EUROPEAN COMMITTEE FOR STANDARDIZATION)
　　The European Committee for Standardization (CEN) is a public standards organization responsible for developing standards for medical devices marketed within the European Union (EU).
　　4) 510(k) Premarket Notification
　　A 510(k) is a premarket submission filed with the FDA for Class I, II, or III medical devices, and it does not require premarket approval. The purpose of the 510(k) submission is to demonstrate that the product is both safe and effective—and essentially equivalent to a legally marketed device already on the market.
　　5) Clinical Evaluation Report (CER - CLINICAL EVALUATION REPORT)
　　The clinical evaluation report provides clinical evidence demonstrating that the medical device will perform as intended, ensuring no safety issues arise during use. European regulations mandate that medical device manufacturers undergo conformity assessment, which includes preparing a CER document, to legally market their products within the EU.
　　6) Premarket Approval (PMA)
　　Pre-market approval is the regulatory pathway required by the FDA for Class III devices to be marketed. The PMA submission process typically involves clinical trials with human participants, as well as laboratory testing, to demonstrate the device's safety and effectiveness.
　　7) Post-Market Surveillance (PMS)
　　Post-market surveillance refers to the process of monitoring medical devices after they have been released for sale and are being used by patients in the market. PMS involves gathering data and feedback on device performance from the marketplace and is a mandatory process required to comply with most regulations and standards, including 21 CFR Part 820, the EU MDR, and ISO 13485:2016.
　　8) IEC 60601
　　IEC 60601 is the standard related to electrical medical devices. Any medical device incorporating electronic components must meet the essential requirements outlined in IEC 60601.
　　Programmable Electrical Medical Systems (PEMS) are a critical component of IEC 60601. PEMS consist of software, firmware, and instruments—components that can be programmed to perform functions essential for medical care or treatment. The standard also covers mechanical safety, labeling, and risk management.
　　9) IEC 62304
　　IEC 62304 is a software framework that outlines software engineering and documentation practices. It is also FDA-approved and provides a risk-based approach applicable throughout the medical device software lifecycle.
　　10) International Organization for Standardization (ISO)
　　The International Organization for Standardization (ISO) is a non-governmental organization composed of experts that develops voluntary international standards based on the specialized knowledge of its members, helping to support and foster innovative solutions aimed at addressing global challenges.
　　11) ISO 13485:2016
　　ISO 13485:2016 is the internationally harmonized standard for Quality Management Systems (QMS) in the medical device industry. To remain compliant with ISO 13485:2016, QMS content must meet the specific, applicable requirements outlined in the standard, as well as any relevant regulatory requirements based on the markets where medical devices are manufactured and marketed.
　　12) ISO 14971:2019
　　ISO 14971:2019 is the latest version of the international standard for medical device risk management. This globally recognized standard provides best practices for applying proactive risk management approaches throughout the entire lifecycle of medical devices.
　　13) ISO 9001
　　ISO 9001 is an international standard that outlines the requirements for a quality management system. According to the ISO 9000 series, 9001 is the only standard that provides manufacturers with a certification pathway, focusing on ensuring users receive high-quality products and services.
　　14) Design for Manufacturing (DFM - DESIGN FOR MANUFACTURE)
　　Design for Manufacturing is a process that optimizes the design of medical devices for production. DFM takes into account manufacturing costs, regulatory compliance, and product performance.
　　15) Design History File (DHF - DESIGN HISTORY FILE)
　　The Design History File contains all documents related to the design and development of medical devices. As required by FDA 21 CFR Part 820, medical device manufacturers in the U.S. market must maintain a DHF.
　　16) Device History Record (DHR-DEVICE HISTORY RECORD)
　　The equipment history record serves as the manufacturing record for medical devices and verifies that the devices were produced according to the information stored in the Device Master Record (DMR). Section 820.184 of the CFR requires manufacturers operating in the U.S. to maintain a DHR, which includes details such as acceptance records for individual product units or batches, unique product identifiers, and product counts.
　　17) Device Master Record (DMR-DEVICE MASTER RECORD)
　　The Device Master Record is a documented compilation of all the information and specifications required for manufacturing medical devices. The DMR includes manufacturing instructions, equipment drawings and specifications, as well as labeling and packaging requirements. The FDA mandates that manufacturers maintain the DMR in accordance with CFR Part 820.181.
　　18) Document Management System (DMS)
　　A Document Management System is a tool used to store and manage documents related to medical device development, while continuously tracking any changes to these documents throughout the product lifecycle. Note that a DMS is not synonymous with a Quality Management System (QMS), which not only stores documents but also places a strong emphasis on regulatory compliance.
　　19) Work in Progress (WIP)
　　Work-in-process is a term used to refer to partially completed products that are either in the manufacturing process or part of the Design History Record (DHR). Inventory that has entered the manufacturing stage, can no longer be classified as raw materials, yet hasn’t yet become a finished product, is categorized as work-in-process.
　　20) Risk Analysis (RA - RISK ANALYSIS)
　　Risk analysis is a method used in risk management to identify specific risks associated with the designs, procedures, or processes employed in medical device manufacturing. The risk assessment process will involve identifying the medical device, relevant personnel, the scope of the risk analysis, and associated timelines. Preliminary hazard analysis, FMEA (Failure Mode and Effects Analysis), and fault tree analysis are all techniques commonly used for conducting risk assessments on medical devices.
　　21) Risk Management (RM - RISK MANAGEMENT)
　　Risk management is the process used by medical device companies to identify, control, and prevent potential hazards and sources of risk or harm during the use of medical devices. ISO 14971:2019 outlines the internationally recognized standard for medical device risk management processes.
　　22) Failure Modes and Effects Analysis (FMEA)
　　Failure Mode and Effects Analysis is a method used to identify potential failures in the design or processes associated with medical devices. FMEA differs from ISO 14971, the international standard for medical device risk management. The FMEA approach can be divided into two parts: Process FMEA for processes and Design FMEA for designs.
　　23) Fault Tree Analysis (FTA)
　　Fault Tree Analysis is an analytical method designed to identify failure points and risks within a quality system. In the medical device manufacturing industry, FTA can be applied throughout the entire risk management process to pinpoint potential sources of risk.
　　24) In Vitro Diagnostic Regulation (IVDR)
　　The European Commission's new IVDR 2017/746, short for In Vitro Diagnostic Regulation, is the EU’s updated regulatory framework for in vitro diagnostic devices, set to come into effect in May 2022. Under the IVDR, all existing IVD devices currently on the EU market must undergo re-certification to meet the new requirements—replacing the previously applicable In Vitro Diagnostic Devices Directive (IVDD).
　　25) Research Use Only (RUO)
　　"Research Use Only" is a technical term used to indicate that a medical device product or instrument is not intended for its primary medical purpose but is instead exclusively for research purposes. Equipment used in IVD product development research is typically labeled "RUO."