The medical device industry is flourishing in the wake of Covid. New medical devices for use in everything from home health to telehealth are being designed and developed at a rapid clip. While most of the innovation is coming from large legacy companies already familiar with the industry, there are many startups and “solopreneurs” entering the game too. Regardless of the size of an organization, knowledge of medical device terminology is the foundation of efficient work, clear communication, and the avoidance of costly errors. As a top medical device engineering and development firm in Silicon Valley, we work with these terms and regulations. For this reason, we’ve compiled an exhaustive list of medical device terms and abbreviations for bookmarking or downloading. Enjoy!
Medical Device Terms and Regulations to Know for Product Developers
21 CFR PART 11
Part 11 of Title 21 in the Code of Federal Regulations, it is mainly referred to as 21 CFR Part 11 or Part 11. It institutes the FDA acceptance criteria for electronic records, electronic signatures, and handwritten signatures on electronic documents. Applies to the medical device, pharmaceutical, biotechnology, and other FDA-regulated industries.
21 CFR PART 820
Quality system regulations (QSR )maintained by the FDA that institute the quality system requirements for all medical device manufacturers in the US. Manufacturers must establish and maintain the appropriate quality system for the medical device they produce to ensure safety and efficacy for its intended use under 21 CFR Part 820.
483 OBSERVATION
An "inspectional observation" notice issued by an FDA inspector to flag possible regulatory violations found during an inspection. A Form 483 observation is published under the FDA jurisdiction. Failure to comply is escalated via a warning letter.
510(K) PRE-MARKET NOTIFICATION
A regulatory pre-market submission for FDA Class I, II, or III medical devices that don't otherwise require pre-market approval. This submission aims to demonstrate a safe and effective device that is substantially equivalent to an already legally marketed device.
APPLICATION LIFECYCLE MANAGEMENT (ALM)
The specification, design, development, and testing of software tools. ALM systems are applied to manage quality and show compliance during the software delivery process.
AUDITING ORGANIZATION (AO)
An organization responsible for auditing medical device manufacturers. They evaluate adherence to quality management system requirements and other medical device regulatory requirements. They can be an independent organization or a Regulatory Authority (RA). When participating in the Medical Device Single Audit Program (MDSAP), AOs may conduct a regulatory audit of a manufacturer to satisfy the relevant requirements of RAs participating in MDSAP.
APPROVED SUPPLIER LIST (ASL)
An internal list maintained by medical device manufacturers to track vendors that have been verified to meet the production company's quality and performance standards.
BILL OF MATERIALS (BOM)
A comprehensive list of raw materials, assemblies, and subassemblies needed to produce a medical device and the quantities required for each.
A BOM is required to carry out change management processes for a medical device.
COMPETENT AUTHORITY (CA)
A body within the government of an EU Member State that translates the requirements of Europe's medical device regulation (MDR) into the national law of each Member State. The Federal Institute for Drugs and Medical Devices (BfArM), for example, is the CA for Germany.
CONFORMITY ASSESSMENT (CA)
An assessment to determine that a medical device is safe and performs as intended by the manufacturer done by an EU Notified Body. Medical devices are required to pass a conformity assessment to obtain CE Marking.
COMPUTER-AIDED DESIGN (CAD)
The software that allows device manufacturers and designers to draft medical device designs with measurements and specifications.
CORRECTIVE AND PREVENTIVE ACTION (CAPA)
A medical device organization's quality system process is the means by which it reduces and/or eliminates possible sources of risk and regulatory non-conformance or noncompliance.
CE MARKING (CE MARK)
The CE mark is a certification that medical device manufacturers must obtain before their products may be sold in the European Union (EU) market.
EU CE Marking is a third-party certification that identifies medical device compliance (where applicable) with the EU's Medical Device Regulations (MDR).
EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)
The European Union's public standards body that develops medical device standards for sale in the EU. CEN is similar to the Food and Drug Administration (FDA) in the US, a body that enforces medical device regulations.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
The U.S. Food and Drug Administration's (FDA) division that regulates the approval of medical devices for sale in the United States market. The CDRH also monitors the performance, manufacturing, and safety of approved medical devices.
CLINICAL EVALUATION REPORT (CER)
A report that provides clinical evidence a medical device will perform as expected, ensuring no safety issues occur while using it. EU regulations require medical device manufacturers must undertake a conformity assessment, including CER certification, to legally market their items in the European Union.
COST OF QUALITY (COQ)
A method of quantifying the financial impact that a quality system and its procedures have on an organization. CoQ may be used by medical device businesses to calculate potential savings and compare them to the costs of internal process improvement.
COMPUTER SYSTEM VALIDATION (CSV)
Refers to a procedure used to show that medical device manufacturing computer systems, including hardware and software, comply with the regulations outlined in 21 CFR Part 11.
CURRENT GOOD MANUFACTURING PRACTICES (CGMP)
The FDA's minimum requirements for manufacturing processes and facilities. The FDA's cGMP standards provide a framework for medical device manufacturers to follow, allowing them greater flexibility in meeting various requirements for quality.
DOCUMENT CHANGE ORDER (DCO)
A formalized change-management procedure for medical devices. The DCO process involves making requests for changes to a document or system in a standardized, trackable manner inside an organization.
DE NOVO
A regulatory pathway classification process implementing a risk-based methodology for new medical devices to be granted market entry for US sales. General controls must demonstrate that the device is safe and effective for its declared purpose in order for a De Novo submission to be approved by FDA.
DEMING CYCLE
A methodology used to monitor quality efficacy that serves as a foundation for traditional quality assurance. The Deming Cycle model is comprised of four parts: plan, do, study, and act, often summarized as PDSA.
DESIGN CONTROLS (DC)
A systematic process defined by the FDA in 21 CFR 820.30 to ensure specific design requirements are met by documented procedures during the design of a medical device. DCs are used to demonstrate that a medical device is safe and effective and performs to expectation. A robust design control system will readily prove your device meets the needs and requirements of its users.
DESIGN DOSSIER (DD)
All the contents of a technical file (TF) used to describe a medical device's design, manufacturing, and performance. A DD will also include documentation that demonstrates conformity to regulatory requirements applicable to the medical device.
DESIGN OF EXPERIMENT (DOE)
A methodology for medical device manufacturers and engineers to validate internal processes, predict process variability, improve and maintain product quality.
DESIGN FOR MANUFACTURE (DFM)
A process for optimizing the design of a medical device specifically for manufacturing. The DFM approach considers both the production and manufacturing cost as well as regulatory compliance and product performance.
DESIGN HISTORY FILE (DHF)
A file with all documentation regarding the design and development of a medical device: under FDA 21 CFR Part 820, medical device manufacturers in the U.S.market must maintain a DHF.
DEVICE HISTORY RECORD (DHR)
A record of production for a medical device that demonstrates it was manufactured according to the device master record (DMR). In the U.S., medical device manufacturers must maintain a DHR under CFR Part 820.184. It contains information like acceptance records for batches of products, unique product identifiers, and product counts.
DEVICE MASTER RECORD (DMR)
A record of the information and specifications needed to produce a medical device. The DMR has instructions for manufacturing, drawings, and specifications of the medical devices. It also contains the requirements for labeling and packaging. The FDA requires manufacturers to maintain a DMR under CFR Part 820.181.
DOCUMENT MANAGEMENT SYSTEM (DMS)
A management tool used to store and manage documents related to the development of a medical device. It can be used to track changes made to documents throughout the product lifecycle. A DMS is not the same as a Quality Management System for storing documents but is also used for focus on regulatory compliance.
ENGINEERING CHANGE ORDER (ECO)
The process triggered when there is an issue with a medical device's performance, cost-effectiveness, or manufacturing process. An ECO is usually followed by an analysis to decide if action should be taken. Depending on the type of change, an ECO has the potential to lead to a CAPA investigation.
ESTABLISHMENT INSPECTION REPORT (EIR)
A report made by FDA when Form 483 is issued after an inspection. The next steps after being issued an EIR from FDA will be determined by the nature and seriousness of the issues reported along with the 483 response. The FDA may decide to issue a warning letter if the deficiencies are severe enough.
ENTERPRISE RESOURCE PLANNING (ERP)
The management of internal business processes of a medical device organization. It is often carried out using ERP tools to collate and organize business data, automate HR processes and other business practices.
IN-VITRO DIAGNOSTIC REGULATION (IVDR)
Europe's newest regulation IVDR 2017/746 for in-vitro diagnostic devices. This regulation will be effective on 26 May 2022. The IVDR requires current IVD devices in the EU marketplace to recertify compliance with the new in-vitro diagnostic devices (IVDD) directives.
EU MEDICAL DEVICE DIRECTIVE (MDD)
The Directive for medical devices sold in the European marketplace (replaced in 2017by the MDR). The aim of which was to bring together laws and standards covering medical devices sold in the European Union.
EU MEDICAL DEVICE REGULATION (EU MDR)
A common abbreviation for the medical device Regulation (EU) 2017/745. This mandate regulates the quality and safety requirements for EU medical devices. The EU MDR supersedes the former medical device directives (MDD) up until 2017. It emphasizes the total product lifecycle approach.
EUROPEAN DATABASE ON MEDICAL DEVICES (EUDAMED)
A database created by the European Commission to more easily enable compliance with European medical device regulations. It is intended to be a multipurpose system used by multiple stakeholders in the medical device industry for the purpose of registration, collaboration, and communication.
FOOD AND DRUG ADMINISTRATION (FDA)
A federal agency within the U.S. Department of Health and Human Services. The FDA approves medical devices for manufacture and distribution within the U.S. Medical device manufacturers working in the U.S. market are subject to FDA inspections, compliance, and requirements of Title 21 of the Code of Regulations.
FAILURE MODES AND EFFECTS ANALYSIS (FMEA)
A method used to identify design or process failures of a medical device. FMEA is different from ISO 14971 for medical device risk management. The FMEA method has two separate parts: PFMEA for processes and DFMEA for designs.
FAULT TREE ANALYSIS (FTA)
An analytical method for the purpose of identifying points of failure and risk within a quality system. FTA can be applied In medical device manufacturing during the risk management activities to identify potential sources of risk.
FREEDOM TO OPERATE (FTO)
Refers to whether device manufacturers are cleared to make or sell their product without infringing on existing third-party rights. Device manufacturers usually declare whether they have FTO in any market they intend to sell a new product.
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR)
(GSPRs) of the new EU MDR that medical device manufacturers are required to comply with. The regulation splits GSPRs into three chapters: general requirements, design and manufacturing requirements, and information supplied with the device requirements.
HAZARD IDENTIFICATION (HID)
A risk management process device manufacturers use to decide whether situations, processes, or items associated with the production of their medical device could potentially cause harm.
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
An FDA exemption that lets investigational devices to be used for testing a medical device for pre-market approval standards. An IDE may be used to accumulate data on the safety and effectiveness of the medical device to be submitted for review by the FDA.
IEC 60601
A standard related to electrical medical equipment. All medical devices containing electronics must meet the IEC 60601 requirements. An integral aspect covered in IEC 60601 is Programmable Electrical Medical Systems. PEMS consists of software, firmware, and equipment that can be programmed to carry out functions in medical care or treatment. The standard also applies to mechanical safety, labeling, and risk management.
IEC 62304
A framework for software that outlines engineering and documentation best practices. It is FDA recognized and provides a risk-based framework used throughout the entire medical device software lifecycle.
INSTRUCTIONS FOR USE (IFU)
Instructional materials used to communicate information relevant to the end-user. These materials need to take into account the capabilities and limitations of the end-user so as to communicate instructions clearly and objectively.
INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)
A voluntary group of international medical device experts who work to standardize medical device standards and regulations. The Global Harmonization Task Force is superseded by The IMDRF.
INSTALLATION QUALIFICATION (IQ), OPERATIONAL QUALIFICATION (OQ), AND PERFORMANCE QUALIFICATION (PQ)
Installation Qualification, Operational Qualification, and Performance Qualification All terms related to medical device software and equipment validation. IQ pertains to the correct installment of software or equipment. OQ concerns meeting the mandated regulatory requirements. PQ assures compliance of the software or equipment performance.
INSTITUTIONAL REVIEW BOARD (IRB)
A body that oversees medical research on humans in the U.S. It ensures that the human rights of all medical research subjects are protected. An IRB has the power to approve or disapprove research and also to request modifications to research practices.
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
A non-governmental organization of experts that provides voluntary international standards based on the proficiency of subject matter experts who are members. The purpose of which is to enable and encourage innovative solutions to worldwide challenges.
ISO 13485:2016
An internationally synthesized standard for medical device quality management systems (QMS). QMS contents need to address the specific, applicable requirements outlined in this standard to align with ISO 13485:2016 as well as the applicable regulatory requirements in alignment to where the medical device will be manufactured and marketed.
ISO 14971:2019
The latest version of the international measure for medical device risk management. This standard is globally recognized and offers best practices for implementing a proactive approach to risk management throughout the full lifecycle of a medical device.
ISO 9001
An international standard that outlines the requirements for quality management systems. It falls under the umbrella of the ISO 9000 standard. ISO 9001 is the only standard that gives a certification pathway for manufacturers. It assumes a specialized focus on making sure users receive good-quality products and services.
IN VITRO DIAGNOSTIC (IVD) DEVICES
References In Vitro Diagnostic devices. IVD, as defined in IVDR (EU) 2017/746, describes devices or equipment intended to be used in vitro for the examination of specimens, including blood and tissue donations originating from the human body.
MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE)
A database for electronic medical device reporting (eMDR). Data is submitted to the FDA by various parties: manufacturers, importers, device user facilities, health care professionals, patients, and consumers.
MEDICAL DEVICE REPORTING (MDR)
A data reporting tool maintained by FDA. It monitors the performance and safety of medical devices after they enter the market. MDR is a voluntary reporting tool and can be used by both medical device manufacturers and consumers for public use.
MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)
A program for medical device manufacturers that allows them to gain access to multiple global markets through a single audit. The five current participating regions of MDSAP are Australia, Brazil, Canada, Japan, and the United States.
MEDICAL DEVICE USER FEE AMENDMENTS (MDUFA)
Changes to the fee structure medical device companies are expected to pay to FDA to register their establishments and medical devices. Also applies to applications or notification submissions made to the FDA.
MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM (MDQMS)
A ground-up quality management system for the medical device industry. It differs from legacy QMS and typically includes templates and workflows that are in line with the medical device industry requirements and best practices.
MANUFACTURING RESOURCE PLANNING (MRP)
A method of compiling, organizing, and planning numerous activities carried out by a medical device manufacturer. This methodology simulates hypothetical scenarios to ensure resources are being effectively implemented. It may also be referred to as ERP.
NOTIFIED BODY (NB)
A third-party auditing organization responsible for assessing the quality and conformity of medical devices looking to enter the EU market.
NONCONFORMANCE REPORT (NCR)
A report used to document non-conforming material discovered during quality control activities or medical device inspection. It both identifies and details issues of non-conformance, the level of impact of non-conformance, how it occurred, and how it will be managed to avoid recurrence.
NONSIGNIFICANT RISK (NSR)
A measure of risk outlined by ISO 14971. A risk can be significant or nonsignificant. Determining the risk category involves assessing the likelihood of direct harm, the probability of harm from not using the medical device, and the probability of harm from misinformation.
OWN BRAND LABELING (OBL)
When a manufacturer sells and markets a medical device in the EU with an existing CE Marking and therefore under its own brand.
ORIGINAL EQUIPMENT MANUFACTURER (OEM)
A company that produces goods used as subparts in products of a third-party company then sells the end products to consumers.
PERSONS RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
A European Commission requirement that manufacturers designate at least one person with the necessary expertise in the discipline of medical devices within their company as the Person Responsible for Regulatory Compliance (PRRC).
PRODUCT DEVELOPMENT (PD)
The process of building a medical device pre-market. The process includes all the design and development of any product, including medical devices.
PRODUCT DATA MANAGEMENT (PDM)
The method of handling data related to medical devices within a software system. PDM tools are used by medical device organizations to gather product data and automate management protocols.
PRODUCT LIFECYCLE MANAGEMENT (PLM)
A system for management and oversight of the development and distribution of a medical product. The process includes design, inception, marketing, regulatory approval, manufacturing, and the post-market phases of a medical device until it drops off the market.
PRE-MARKET APPROVAL (PMA)
A regulatory pathway to get a medical device to market that is required for Class III devices by FDA regulations. The submission process for PMA usually involves human clinical trials and laboratory testing to demonstrate the safety and efficacy of the device.
POST-MARKET SURVEILLANCE (PMS)
The process of monitoring a medical device after it is released into the market for sale, distribution, and use by patients. The PMS process involves gathering data and feedback on the device's performance within the market. It is a required process for compliance with several regulations, including 21 CFR Part 820, EU MDR, and ISO 13485:2016.
PROOF OF PRINCIPLE (POP)
The demonstration that shows the initial concept behind a medical device is achievable. A POP usually includes success criteria that must be met to proceed with product development.
PRODUCTION PLANNING AND CONTROL (PPC)
A process used to organize medical device production, design, and development activities, and manufacturing. A PPC process as a whole typically is made up of inputs, outputs, and control systems. The Regulations for this type of design and development planning are in FDA CFR 21 Part 820.30.
QUALITY ASSURANCE (QA)
A method used to prevent defective medical products. QA professionals work to improve medical product development and testing processes. They also maintain regulatory compliant marketing and distribution processes. A quality management system is a QA tool in and of itself and is used as a single trusted reference for all quality policies and procedures for the medical product.
QUALITY CONTROL (QC)
A system that focuses on identifying defects in a medical device's post-production and prior to medical product distribution. Quality control is used to ensure medical products conform to requirements and performance criteria at the point of the end-user interaction. QC is a complementary aspect of a QMS.
QUALITY MANAGEMENT SYSTEM (QMS)
An organizational tool used to implement and maintain activities, documents, and tasks as they relate to responsibilities, processes, procedures, and resources. A QMS is critical to regulatory compliance and the production of safe and efficacious medical devices. A basic quality system includes design controls, risk management, document control, records management, and supplier management.
QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)
An FDA inspection, also known as the QSIT method, that uses a top-down approach to review the four subsystems within an organization's QMS. It involves the FDA inspector starting by reviewing a company's procedures before getting deeper into the quality records.
QUALITY SYSTEM RECORD (QSR)
A record used as a source file for all documentation, procedures, and records in a QMS. Medical device companies can use QSR as a reference to guide other aspects of their QMS. QSR may also refer to Quality System Regulation
QUALITY SYSTEM REGULATION (QSR)
Requirements based on methods for facilities and controls used to carry out all phases of medical device lifecycle processes. It includes designing, manufacturing, storing, labeling, packaging, installing, and servicing of medical devices intended for human use.
REGULATORY AFFAIRS (RA)
A professional in the medical device industry installed in a strategic role throughout a medical device product lifecycle. It could be the formulation of a market entry strategy for satisfying legal hurdles, regulatory submission protocol, and/or post-market surveillance methods. The RA's role is essential for communicating and executing appropriate strategies for medical regulatory compliance.
RISK ANALYSIS (RA)
A method used in risk management to flush out risks associated with a design, procedure, or process used in the manufacturing of a medical device. The process encompasses identifying the medical device, the scope of the risk analysis, the relevant dates, and the persons involved. Methods used to carry out risk analysis for a medical device include preliminary hazard analysis, FMEA, and fault tree analysis.
RISK MANAGEMENT (RM)
A process used by medical device companies to identify, control, and prevent risks, hazards, and sources of harm that could come about during the use of a medical device. ISO 14971:2019 is the internationally recognized standard for medical device RM processes.
RESEARCH USE ONLY (RUO)
A term used to show that a medical device, instrument, or product does not have an intended medical purpose; rather is being used for research purposes only.
SOFTWARE AS A MEDICAL DEVICE (SAMD)
A class of software for use in medical functions that do not need a hardware component to perform that function. Software used to diagnose, prevent, cure, or mitigate disease are all considered classes of SaMD.
SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)
A formal notice sent by a medical device organization to a supplier because of an observance of non-conforming products or materials. The purpose of the SCAR is to get action from the supplier and to correct the issue.
SUBSTANTIAL EQUIVALENCE (SE)
A regulatory requirement by FDA for clearing new medical products for market through a 510(k) pre-market submission. To do so, a company must demonstrate its device is as safe and effective as an established one. SE is a requirement for regulatory submissions when a pre-market approval is not required.
SAFE MEDICAL DEVICES ACT (SMDA)
A 1990 law establishing HHS as the governing authority over medical device user facilities for the reporting of medical devices that may have caused serious illness, injury, or death.
STANDARD OPERATING PROCEDURE (SOP)
An internal procedure by which organizations standardize a routine process for easy repetition. An SOP is usually a written document made up of instructions to be followed. As part of their QMS, medical device companies are required to create and maintain SOPs for all routine processes.
STATISTICAL PROCESS CONTROL (SPC)
A method used to control a process by utilizing statistical techniques. It entails compiling data from a process and building a cause and effect model to predict potential outcomes.
SIGNIFICANT RISK (SR)
A measure of risk as defined by ISO 14971. Under this regulation, any device that could pose a serious risk to the health and/or safety of a human subject must be categorized as SR.
SINGLE-USE DEVICES (SUDS)
Thee are disposable devices for the purpose of being used for one patient in a singular event or procedure. These devices are created to be disposed of after use and cannot be sanitized or re-used.
SUMMARY TECHNICAL DOCUMENTATION (STED)
The format manufacturers use to log information on how a medical device was designed, developed, and manufactured for submission to an RA or Notified Body. Technical Files require the STED format.
TECHNICAL FILE (TF)
The file or dossier for Class III medical devices. It encompasses specific details about a medical device's design, function, composition, intended use, and a clinical evaluation. To obtain a CE marking for a device, the TF is needed.
UNIQUE DEVICE IDENTIFICATION (UDI)
A system established by the FDA for cataloging and identifying all medical devices for sale in the U.S. market. This system assigns each medical device a custom identifier that can be read by both humans and machines. A UDI is different from a UPC because it can only be used to identify a medical device on the FDA website via the AccessGUDID portal.
UNIVERSAL PRODUCT CODE (UPC)
A barcode and 12-digit number printed on retail packaging. The code is used by retailers to track inventory on all products, but for medical devices, it is considered to be an alternative tracking method to the official identification system used by FDA, the UDI.
VERIFICATION AND VALIDATION (V&V)
Activities for testing and confirming whether a medical device meets the design criteria and procedures and is ready to be released for manufacturing. Design verification ensures a medical device has been designed correction and validated. The procedures involve careful tests, trials, and analyses.
VOLUNTARY ACTION INDICATED (VAI)
A term used by the FDA in the EIR to highlight regulatory action is not required following notice of objectionable conditions or practices during an inspection. OAI s the opposite of this and would indicate regulatory or administrative action is required by FDA to correct an issue.
WARNING LETTER (WL)
An official notice made by FDA in response to regulatory violations. Often these violations have been escalated from a 483 observation. Examples of violations include wrongful claims about the device or missing design controls. A WL will give a detailed explanation of the violation and corrective action plan requirements for the medical device company.
WORK IN PROGRESS (WIP)
A term used to refer to a partially finished medical device in the manufacturing process or within a design history record (DHR). Once inventory enters the manufacturing process, it can no longer be classed as raw materials but is also not a finished product, so it is classed as WIP.