510(k) Predicate Device
510(k) Predicate Device is a legally marketed medical device that a manufacturer cites in a Premarket Notification to demonstrate substantial equivalence for a new…
Explore essential medical device, diagnostics, engineering, manufacturing, quality, and regulatory terminology—explained by SJML’s MedTech experts.
Search and explore essential terminology across medical device design, manufacturing, quality, regulatory affairs, standards, technologies and the complete product lifecycle.
510(k) Predicate Device is a legally marketed medical device that a manufacturer cites in a Premarket Notification to demonstrate substantial equivalence for a new…
Acceptance criteria are the predefined, measurable requirements a medical device, component, process step, or test result must meet to be judged conforming. They are…
An adverse event is any undesirable medical occurrence, injury, or harmful effect experienced by a patient, user, or other person associated with the use…
Assay Development is the process of designing, optimizing, and validating a diagnostic test method—the reagents, protocols, and detection chemistry that measure a specific analyte—so…
Authorized Representative (AR) An Authorized Representative (AR) is a natural or legal person established in the European Union who accepts a written mandate from…
A batch record is the compiled set of production records proving that a specific batch or lot of a medical device was built according…
Bench testing is a non-clinical laboratory evaluation of a medical device or its components on a test bench, under controlled conditions and without human…
Benefit-Risk Determination is the structured analysis that weighs a medical device’s expected clinical benefits against its residual risks for the device’s intended purpose. Manufacturers…
A Bill of Materials (BOM) is a structured list of every component, part, subassembly, raw material, and quantity needed to build a medical device.…
Biocompatibility Testing is the evaluation of how a medical device and its materials interact with the body to confirm they do not cause harmful…
CDSCO is the Central Drugs Standard Control Organization, India’s national regulatory authority for drugs and medical devices. Operating under the Ministry of Health and…
CE Marking is a mandatory conformity mark that shows a medical device meets the safety, performance, and labeling requirements of EU Regulation 2017/745 (MDR)…
Change Control is the formal process medical device manufacturers use to identify, evaluate, document, and approve changes to a device’s design, manufacturing process, or…
Clean Room is a controlled manufacturing environment where airborne particle concentration, and often temperature, humidity, and pressure, are held within defined limits to protect…
Clinical data is information about a medical device’s safety or performance that comes from its use in or on human subjects. Under EU MDR…
Clinical Evaluation Plan (CEP) is the pre-specified document that defines how a medical device manufacturer will generate, collect, and appraise clinical data to demonstrate…
Clinical Evaluation Report (CER) is a regulatory document that presents the systematic collection, appraisal, and analysis of clinical data for a medical device, showing…
Clinical evidence is the body of clinical data and clinical evaluation results that, in sufficient amount and quality, lets a qualified assessor confirm a…
Clinical investigation is a systematic, planned study of a medical device in human subjects to assess its safety and clinical performance for regulatory purposes.…
Clinical performance is a medical device’s ability to achieve its intended clinical purpose in the target population. Under EU IVDR, it describes results that…
Common Specifications (CS) are legally binding sets of technical or clinical requirements adopted by the European Commission under Article 9 of EU MDR 2017/745…
Compassionate Use is a regulatory pathway that lets a patient with a serious or life-threatening condition access an investigational medical device outside a clinical…
A Competent Authority is the national government body in each EU or EEA member state responsible for implementing and enforcing the Medical Device Regulation…
Complaint Handling is the regulated process a medical device manufacturer uses to receive, document, evaluate, and investigate any communication alleging a deficiency in a…
Complaint handling is the systematic process a medical device manufacturer uses to receive, record, evaluate, investigate, and respond to communications alleging that a device…
Computer-Aided Design (CAD) is software used to create precise 2D drawings and 3D models of medical device parts, assemblies, and enclosures. In MedTech, CAD…
Concept Feasibility Study is an early-stage assessment in medical device development that tests whether a proposed device concept can work technically, satisfy user and…
Conformity assessment is the documented process by which a medical device manufacturer demonstrates that a device meets the applicable regulatory and safety requirements before…
A Contract Development and Manufacturing Organization (CDMO) is a company that provides outsourced design, engineering, and manufacturing services for medical devices on behalf of…
Contract Manufacturing Organization (CMO) is a company that manufactures medical devices, components, or subassemblies to another firm’s specifications under contract. The client, usually the…
Corrective and Preventive Action (CAPA) is a formal quality system process that medical device manufacturers use to investigate problems, correct existing nonconformities, and stop…
Critical-to-Quality (CtQ) is a measurable product or process characteristic that must meet a defined specification to satisfy patient safety, performance, or regulatory requirements. In…
Cybersecurity is the practice of protecting a medical device, its software, and its connected systems from unauthorized access, tampering, and disruption across the product…
De Novo classification is an FDA pathway that lets a novel medical device of low to moderate risk reach the U.S. market without a…
Declaration of Conformity (DoC) is a legally binding document in which a medical device manufacturer states, under its own responsibility, that a device meets…
Design Controls are a formal, documented set of practices that medical device manufacturers use to plan, develop, verify, validate, and transfer a device design…
Design Dossier is the compiled technical documentation a manufacturer submits to a Notified Body to prove a high-risk medical device meets EU regulatory requirements.…
Design Failure Mode and Effects Analysis (DFMEA) is a structured engineering method that identifies how a product design could fail, evaluates the severity, likelihood,…
Design for Excellence (DfX) is a set of design methodologies that optimize a medical device for specific downstream goals such as manufacturability, reliability, serviceability,…
Design for Manufacturability (DfM) is an engineering practice that shapes a medical device’s design so it can be made reliably, repeatably, and at acceptable…
Design Freeze is a controlled milestone in medical device development when the design is locked, and no further changes are permitted without formal change…
Design History File (DHF) is a compilation of records describing the design history of a finished medical device. Mandated by FDA 21 CFR Part…
Design Input is the set of physical, performance, safety, regulatory, and user requirements that define what a medical device must do before detailed design…
Design outputs are the documented results of the design process: the drawings, specifications, software source code, bills of materials, and acceptance criteria that define…
Design Transfer is the documented process of converting a finalized medical device design into validated production specifications, so manufacturing can reliably reproduce the device.…
Design Validation is the process of confirming, through objective evidence, that a finished medical device meets defined user needs and intended uses under actual…
Design Verification is the documented process of confirming, through objective evidence, that a medical device’s design outputs meet its specified design inputs. It answers…
Device classification is the regulatory process of assigning a medical device to a risk category that determines its market pathway. Frameworks like the FDA…
Device History Record (DHR) is the set of production records proving that a specific device, lot, or batch was built according to its approved…
Device Master Record (DMR) is the compilation of records containing the procedures and specifications for a finished medical device, covering device design specs, production…
Device registration is the regulatory process of formally recording a company and its medical devices with a market’s health authority before or upon market…
Electromechanical devices are medical products that combine electrical and mechanical subsystems, often with embedded software, to sense, actuate, or deliver therapy. They range from…
Electromyography (EMG) is a diagnostic and monitoring technique that records the electrical activity generated by skeletal muscle fibers, typically through surface or needle electrodes.…
Electrophoresis (Diagnostic) is a laboratory technique that separates charged biomolecules, such as proteins, hemoglobin, or nucleic acids, by moving them through a gel or…
Electrostatic Discharge (ESD) Control is the set of administrative and technical measures that prevent static charge from damaging electronic parts during handling, assembly, test,…
Electrotherapy is the therapeutic application of electrical current to nerves, muscles, or soft tissue through skin-mounted or implanted electrodes. In medical devices, it covers…
Embedded systems are dedicated computing units, combining a processor, firmware, and supporting electronics, built into a larger product to control specific functions. In medical…
EMC Testing is the process of confirming that a medical device does not emit electromagnetic disturbances that interfere with nearby equipment and maintains its…
EMI testing is the set of measurements that confirm a medical device neither emits electromagnetic energy that disrupts nearby equipment nor malfunctions when exposed…
End of Life (EOL) is the final phase of a medical device’s lifecycle, when a manufacturer stops production, sales, or support and plans for…
Endoscopic imaging is the use of miniature cameras, light sources, and optical or video systems mounted on rigid or flexible endoscopes to capture real-time…
Engineering Change Order (ECO) is a formal, documented instruction that authorizes and records a change to a released medical device design, component, specification, or…
Engineering Change Request (ECR) is a formal, documented proposal to modify a released medical device, component, process, or specification. It records the problem, the…
Equivalence (EU MDR) is the regulated demonstration that a medical device is sufficiently similar to an already-marketed device that clinical data from that device…
EU MDR (Regulation (EU) 2017/745) is the European Union regulation governing the design, manufacture, and marketing of medical devices sold in the EU. It…
EUDAMED is the European Database on Medical Devices, the central IT system established under EU MDR 2017/745 that registers economic operators, devices, certificates, and…
FDA 21 CFR Part 803 is the U.S. Medical Device Reporting (MDR) regulation. It requires manufacturers, importers, and device user facilities to report certain…
FDA 21 CFR Part 820 (QMSR) is the US Food and Drug Administration’s Quality Management System Regulation for medical devices. Effective February 2, 2026,…
FDA 510(k) is a premarket notification submitted to the U.S. Food and Drug Administration to show that a medical device is substantially equivalent to…
FDA Pre-Submission (Q-Sub) is a voluntary request that lets a medical device sponsor obtain written feedback or a meeting with the FDA before filing…
Field Safety Corrective Action (FSCA) is a corrective action a medical device manufacturer takes, for technical or medical reasons, to prevent or reduce the…
Field Safety Notice (FSN) is a written communication that a medical device manufacturer sends to users, customers, and distributors to explain a Field Safety…
Firmware is the low-level software stored in a medical device’s non-volatile memory that controls the hardware directly. It sits between the physical electronics and…
First Article Inspection (FAI) is a documented verification that the first units built on production tooling, by production processes and trained operators, conform to…
Focused Ultrasound (FUS) is a therapeutic and diagnostic technology that directs acoustic energy from an array of transducer elements to a precise focal point…
Fractional Radiofrequency (FRF) is a skin-treatment technology that delivers radiofrequency energy through an array of electrodes to create a pixelated pattern of controlled thermal…
Gap analysis is a structured QARA method that compares a medical device organization’s current quality system, technical documentation, or processes against the requirements of…
General Safety and Performance Requirements (GSPR) are the set of mandatory safety and performance criteria in Annex I of the EU Medical Device Regulation…
Good Manufacturing Practice (GMP) is the body of regulatory requirements governing how medical devices are designed, manufactured, packaged, labeled, stored, installed, and serviced, so…
Harmonized standards are European standards adopted by CEN or CENELEC on a request from the European Commission to support EU legislation. Under EU MDR…
High-Intensity Focused Ultrasound (HIFU) is a non-invasive medical technology that concentrates acoustic energy from an external transducer onto a precise target inside the body,…
Human Factors Engineering (HFE) is the discipline of applying knowledge about human abilities, limitations, and behavior to medical device design so the device can…
IEC 60601 is a family of international standards, published by the International Electrotechnical Commission, that define the basic safety and essential performance requirements for…
IEC 60601-1 is the international safety standard for medical electrical equipment, defining requirements for basic safety and essential performance of devices that connect to…
IEC 60601-1-2 is the international collateral standard for electromagnetic compatibility (EMC) of medical electrical equipment and systems. It sets emissions and immunity requirements so…
IEC 60601-1-6 is the collateral usability standard in the IEC 60601 family for medical electrical equipment. It requires manufacturers to apply a usability engineering…
IEC 62133 is an international safety standard for portable sealed rechargeable cells and batteries containing non-acid electrolytes. Split into Part 1 (nickel systems) and…
IEC 62304 is the international standard that defines the software life cycle processes for medical device software. It specifies the planning, development, maintenance, risk…
IEC 62304 is the international standard that defines the software lifecycle processes for medical device software. It sets requirements for planning, development, maintenance, risk…
IEC 62366-1 is the international standard that defines a usability engineering process for medical devices, ensuring the user interface is designed to minimize errors…
IEC 81001-5-1 is the security lifecycle standard for health software. It defines the security activities a manufacturer must perform across the life cycle, from…
IFU (Instructions for Use) is the information a manufacturer supplies with a medical device so users can operate it safely and as intended. It…
Impedance Spectroscopy is a measurement technique that applies a small alternating current across a range of frequencies to a material, tissue, or electrode interface…
In-Process Controls (IPC) are the checks, tests, and monitoring activities performed during manufacturing, rather than after it, to confirm that a device or its…
An incident report is a formal notification a medical device manufacturer submits to a regulatory authority when a marketed device is linked to a…
Intended population is the specific group of patients a medical device is designed to be used on or by, defined by characteristics such as…
Intended purpose (EU MDR) is the use for which a medical device is intended, based on the manufacturer’s label, instructions for use, promotional materials,…
Intended Use is the manufacturer’s formal statement of what a medical device is for: its medical purpose, target users, patient population, and use environment.…
International registration is the process of obtaining regulatory authorization to legally sell a medical device in a target country or region. It combines device…
ISO 10993 is a series of international standards for the biological evaluation of medical devices. It defines how to assess biocompatibility, the biological safety…
ISO 11135 is the international standard that specifies requirements for the development, validation, and routine control of an ethylene oxide (EO) sterilization process for…
ISO 11137 is an international standard series that specifies requirements for the development, validation, and routine control of radiation sterilization of health care products.…
ISO 11607 is the international standard that defines requirements for packaging used with terminally sterilized medical devices. Split into two parts, it covers the…
ISO 13485 is the international standard for quality management systems (QMS) specific to organizations that design, produce, install, or service medical devices. It sets…
ISO 14155 is the international standard that defines Good Clinical Practice (GCP) for clinical investigations of medical devices in human subjects. It sets requirements…
ISO 14644-1 is the international standard that classifies cleanroom air cleanliness by airborne particle concentration. It assigns an ISO Class from 1 to 9…
ISO 14971 is the international standard that defines a process for applying risk management to medical devices, including in vitro diagnostic (IVD) devices and…
ISO 15223 is the international standard that defines the graphical symbols medical device manufacturers use to convey label and packaging information, such as manufacturer,…
ISO 17025 is the international standard, formerly ISO/IEC 17025, that sets requirements for competence, impartiality, and consistent operation in testing and calibration laboratories. In…
ISO 27001 is an international standard that specifies the requirements for an information security management system (ISMS): a structured set of policies, processes, and…
ISO 9001 ISO 9001 is the international standard for a quality management system (QMS) that any organization can adopt, regardless of sector or size.…
ISO/IEC 42001 is the first international standard for an artificial intelligence management system (AIMS). Published by ISO and IEC in 2023, it sets requirements…
IVDR (EU 2017/746) is the European Union regulation governing the design, manufacture, and market placement of in vitro diagnostic (IVD) devices sold in EU…
Jira (Design Tool) is Atlassian’s issue and project tracking software, widely used in medical device development as an application lifecycle management (ALM) backbone for…
Lab-on-a-Chip (LOC) is a technology that shrinks laboratory functions such as sample handling, mixing, separation, and detection onto a single microfluidic chip, often just…
A Lateral Flow Assay (LFA) is a paper-based diagnostic format that detects a target analyte in a liquid sample without requiring laboratory infrastructure, instrumentation,…
Lean Manufacturing is a production philosophy that removes non-value-adding activity from a process while protecting product quality. In medical devices, it applies inside a…
Legacy devices are medical devices that hold valid CE certificates issued under the old EU directives (MDD 93/42/EEC or AIMDD 90/385/EEC) and remain on…
Lifecycle management is the practice of governing a medical device across its entire life, from concept and design through manufacturing, market release, post-market surveillance,…
Literature Review (Clinical) is a systematic, documented search and appraisal of published scientific literature used to gather clinical data on a medical device, its…
MDCG guidance documents are non-binding guidance issued by the Medical Device Coordination Group to explain how the EU Medical Device Regulation (MDR 2017/745) and…
MDR Annex I (GSPR) is the set of General Safety and Performance Requirements defined in Annex I of EU Regulation 2017/745. These 23 mandatory…
MDR Annex II / III are the two annexes of EU Regulation 2017/745 that define the technical documentation a medical device manufacturer must compile…
Mechanical design is the engineering discipline that defines a medical device’s physical form, structure, materials, and moving parts so it performs its intended function…
Medical Device Directive (MDD 93/42/EEC) is a 1993 European Union directive that sets the essential requirements, classification rules, and CE marking process for most…
Medical device labeling is the full set of information that accompanies a device, including the label on the unit itself, packaging inserts, instructions for…
Medical Device Reporting (MDR) is the FDA’s mandatory system, set out in 21 CFR Part 803, that requires manufacturers, importers, and device user facilities…
Medical Device Single Audit Program (MDSAP) is an international program that lets one audit of a manufacturer’s quality management system satisfy the regulatory requirements…
A Microchannel is an enclosed fluid pathway with cross-sectional dimensions typically between 1 and 1000 micrometers, fabricated into a chip or cartridge substrate to…
Microfluidics is the science and engineering of controlling small volumes of fluid, usually inside channels between 10 and 500 micrometers wide, to mix, separate,…
Microneedling is a minimally invasive dermal technology that uses an array of fine needles, typically 0.25 mm to 3 mm long, to create controlled…
Monopolar vs. Bipolar Radiofrequency is a comparison of two electrode configurations that deliver RF current to tissue in electrosurgical and RF-based medical devices. Monopolar…
Neuromuscular Electrical Stimulation (NMES) is a form of electrotherapy that delivers pulsed electrical current through electrodes placed on the skin to elicit involuntary contraction…
Nonconformance is the failure of a product, process, or service to meet a specified requirement within a medical device quality system. Under ISO 13485…
Non-Conformance Report (NCR) is a controlled quality record that documents a product, component, material, or process that fails to meet a specified requirement. It…
A Notified Body is an independent, third-party organization designated by an EU member state to assess whether a medical device and its manufacturer’s quality…
Obsolescence Management is the structured process of anticipating and resolving the loss of parts, materials, or software a medical device depends on, before that…
Optical Coherence Tomography (OCT) is a non-invasive imaging technique that uses low-coherence light and interferometry to produce high-resolution, cross-sectional images of biological tissue. It…
Optics and photonics (medical) is the engineering discipline covering the generation, control, and detection of light for medical devices used in imaging, diagnosis, therapy,…
Original Equipment Manufacturer (OEM) is the company that designs and builds a medical device or component that another company may then sell under its…
Performance Evaluation (IVDR) is the continuous, documented process by which an IVD manufacturer assesses data to demonstrate a device’s scientific validity, analytical performance, and…
Periodic Safety Update Report (PSUR) is a regulatory document that manufacturers of Class IIa, IIb, and III medical devices prepare under EU MDR 2017/745,…
PFAS Compliance is the practice of identifying, controlling, and where necessary eliminating per- and polyfluoroalkyl substances (PFAS) across medical device materials, components, and manufacturing…
The Phase Gate Process is a structured project management method that splits medical device development into defined phases separated by decision points called gates.…
PMCF (Post-Market Clinical Follow-Up) is a continuous, proactive process of collecting and evaluating clinical data on a CE-marked medical device after it reaches the…
Point-of-Care (PoC) Testing is in vitro diagnostic testing performed at or near the patient rather than in a central laboratory, using compact analyzers or…
Post-Market Clinical Follow-Up (PMCF) is the continuous, proactive collection and evaluation of clinical data on a CE-marked medical device once it is on the…
Post-Market Surveillance (PMS) is the systematic, ongoing process by which a medical device manufacturer collects and analyzes data about a device once it is…
Post-Market Surveillance Plan is a manufacturer-authored document that defines how real-world safety and performance data will be collected, analyzed, and acted upon after a…
Post-Market Surveillance Report (PMSR) is the report that manufacturers of Class I medical devices must prepare under Article 85 of EU MDR 2017/745. It…
Precision manufacturing is the production of components and assemblies to tightly controlled dimensional, material, and surface tolerances using qualified equipment, statistical process control, and…
Premarket Approval (PMA) is the FDA’s most stringent premarket review pathway for Class III medical devices. Governed by 21 CFR Part 814 and Section…
Printed Circuit Board Assembly (PCBA) is the process of populating a bare printed circuit board with electronic components to build a working circuit and…
Process Validation is documented evidence that a manufacturing process, operated within defined parameters, consistently produces output meeting predetermined specifications. Medical device makers validate any…
Product architecture is the high-level structure of a medical device: how its functions are divided into subsystems (mechanical, electronic, and software) and how those…
Product Sustenance Engineering is the engineering discipline that keeps a released medical device safe, compliant, manufacturable, and available from commercial launch through end of…
Program management in medical device development is the coordinated planning and control of a device program across its full lifecycle, aligning engineering, quality, regulatory,…
Proof of Concept (PoC) is a preliminary demonstration that a proposed medical device idea, technology, or design approach can work as intended. Teams build…
A prototype is a physical or functional build of a medical device design, created to test specific features, performance, or manufacturability before the design…
QARA is the combined medical device function that pairs Quality Assurance (QA) with Regulatory Affairs (RA). QA maintains the quality management system and confirms…
Quality Management System (QMS) is the documented structure of policies, processes, procedures, and records that a medical device organization uses to control design, production,…
Quality Management System Regulation (QMSR) is the U.S. FDA rule, effective February 2, 2026, that governs 21 CFR Part 820. It incorporates ISO 13485:2016…
Quality plans are project-specific documents that state which procedures, resources, records, and acceptance criteria apply to a particular device, process, or contract, and who…
Radiofrequency (RF) energy (medical) is electromagnetic energy in the roughly 100 kHz to 300 GHz range applied by medical devices to cut, coagulate, ablate,…
Reactive Oxygen Species (ROS) are chemically reactive molecules and free radicals derived from oxygen, including superoxide, hydrogen peroxide, and hydroxyl radicals. In medical devices,…
Regulatory audit is a formal, evidence-based examination of a medical device organization’s quality management system, records, and processes against a defined regulation or standard…
Regulatory Strategy is the documented plan that defines how a medical device will achieve and maintain market authorization across target regions. It maps the…
Regulatory Sustenance is the ongoing work of keeping a medical device compliant after market launch. It covers maintaining technical documentation, risk management files, the…
Requirements Traceability Matrix (RTM) is a structured document that links each product requirement to its source, design output, verification test, and validation result. In…
Residual risk is the risk remaining after all feasible risk control measures have been applied to a medical device. Defined in ISO 14971, it…
Risk Management File is the collection of records and documents a medical device manufacturer produces through the ISO 14971 risk management process. It captures…
Risk-Benefit Analysis is the process of weighing a medical device’s clinical benefits against its residual risks to decide whether the device is acceptable for…
Root Cause Analysis (RCA) is a structured investigation method used to identify the underlying cause of a nonconformity, failure, or complaint rather than its…
Serious Adverse Event (SAE) is any unintended incident associated with a medical device that directly or indirectly resulted in, or could have led to,…
Service life is the period, defined by the manufacturer, during which a medical device is expected to remain safe and perform as intended under…
Six Sigma is a data-driven methodology for reducing variation and defects in a process. In medical device manufacturing, it is applied through the DMAIC…
Software as a Medical Device (SaMD) is software intended for one or more medical purposes that achieves those purposes without being part of a…
Software in a medical device (SiMD) is embedded software that is integral to a physical medical device and required for it to achieve its…
Software Lifecycle (IEC 62304) is the international standard that defines the processes, activities, and tasks for developing and maintaining medical device software. It sets…
Spectrophotometry is a quantitative measurement technique that determines how much light a sample absorbs or transmits at specific wavelengths. In medical devices, it enables…
State of the Art (SOTA) is the developed stage of current technical capability and accepted clinical practice for a given device type, drawn from…
Statistical Process Control (SPC) is a method of monitoring a manufacturing process using statistical tools, most often control charts, to distinguish normal random variation…
Sterilization validation is the documented process of proving that a defined sterilization cycle reliably reduces microorganisms on a medical device to a specified sterility…
Substantial equivalence is the FDA standard used in a 510(k) premarket notification to show that a new medical device is as safe and effective…
Summary of Safety and Clinical Performance (SSCP) is a public-facing document required under EU MDR 2017/745 Article 32 for implantable and Class III devices,…
A supplier audit is a planned, documented evaluation of a supplier’s quality management system, processes, and records to confirm they can consistently meet medical…
Supplier qualification is the documented process a medical device manufacturer uses to evaluate, approve, and monitor suppliers of components, materials, and outsourced services. It…
Supply chain management is the planning, sourcing, qualification, and control of every supplier, component, and logistics step that feeds a medical device. In regulated…
Sustaining engineering is the set of engineering activities that keep a medical device safe, compliant, and manufacturable after market release. It covers change control,…
Systems engineering is a disciplined, cross-functional approach to designing a medical device as an integrated whole, translating user needs into requirements, architecture, and verified…
Technical documentation is the structured body of evidence a medical device manufacturer compiles to demonstrate that a device meets applicable safety, performance, and regulatory…
Technical File is the structured technical documentation a medical device manufacturer compiles to demonstrate that a device conforms to EU MDR 2017/745. Defined mainly…
Technology Refresh is the planned replacement of aging hardware, software, or components in a medical device or in the equipment that builds it to…
Therapeutic ultrasound is an active medical device technology that delivers acoustic energy into body tissue to produce heating, mechanical, or ablative effects for treatment…
Total Cost of Ownership (TCO) is the full cost of a medical device across its entire lifecycle, not just its purchase price. It covers…
Traceability is the ability to link a finished medical device back to the materials, components, processes, equipment, and personnel that produced it, and forward…
Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive electrotherapy modality that delivers low-voltage electrical pulses through skin-surface electrodes to modulate peripheral nerve activity for…
Unique Device Identification (UDI) is a system that assigns each medical device a globally unique code, letting regulators, hospitals, and manufacturers trace a specific…
Usability engineering is the structured process medical device manufacturers use to analyze, specify, design, and evaluate how people interact with a device, so that…
User needs are the documented requirements that describe what a medical device must accomplish for the people who use it, including patients, clinicians, and…
Value Analysis / Value Engineering (VAVE) is a structured method for raising the value of a medical device by studying what each function costs…
Verification and Validation (V&V) is the paired process that confirms a medical device is built correctly and that it meets its intended use. Verification…
Vigilance is the medical device process for detecting, evaluating, and reporting serious incidents and field safety corrective actions to regulators after a product reaches…
Vigilance reporting is the regulated process by which a medical device manufacturer notifies competent authorities of serious incidents and field safety corrective actions involving…
Visual inspection is the systematic examination of a device, component, subassembly, or label against documented acceptance criteria, performed by a trained operator or an…
Waveform Generator (Medical) is a signal source that produces defined electrical waveforms, either as the therapeutic or diagnostic output of a medical device, or…
Wearable medical devices are body-worn electronic products that sense, monitor, or deliver therapy while a person goes about daily life. Regulated as medical devices…
Work Instruction (WI) is a controlled document that describes, step by step, how a single task is performed at the point of use. In…
Yield rate is the percentage of units that pass all inspection and test steps in a manufacturing process without rework or scrap. In medical…
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