131 terms to explore
21 CFR Part 11
FDA requirements that make electronic records and electronic signatures trustworthy, reliable and equivalent to paper records and handwritten signatures.
21 CFR Part 210
FDA current good manufacturing practice (cGMP) general provisions for manufacturing, processing, packing and holding drugs.
21 CFR Part 211
FDA cGMP requirements for finished pharmaceuticals for human or veterinary use.
21 CFR Part 820
The FDA regulation for medical device quality systems. Since February 2, 2026 it is the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference.
483 (FDA Form 483)
A list of inspectional observations an FDA investigator issues at the close of an inspection when conditions may violate FDA requirements.
510(k)
A U.S. premarket notification that demonstrates a new device is substantially equivalent to a legally marketed predicate device.
513(g)
A request asking FDA for its view on how a device is classified and which regulatory requirements apply.
Accessory
An article intended by its manufacturer to be used together with one or more devices so they can be used as intended, or to directly support their function.
Active Device
A device whose operation depends on a source of energy other than energy generated by the human body or gravity.
Adverse Event
Any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users or others, whether or not related to the device.
Analytical Performance
The ability of a diagnostic device to correctly detect or measure a particular analyte.
Audit
A systematic, independent and documented process for obtaining objective evidence and evaluating it to determine how far audit criteria are fulfilled.
Audit Readiness
The state of having processes, records and people prepared to demonstrate compliance confidently during an internal, certification or regulatory audit.
Authorized Representative
A legal entity established in a market (for example, the EU) that a non-resident manufacturer mandates to act on its behalf for specified regulatory tasks.
Benefit-Risk Determination
An analysis weighing the benefits of a device against its risks, in the context of its intended purpose and the current state of the art.
BIMO
Bioresearch Monitoring: the FDA program of inspections that verifies the integrity of clinical data and the protection of research subjects.
CAPA
Corrective and Preventive Action: a structured process to investigate problems, eliminate root causes and prevent occurrence or recurrence.
CE Marking
The marking by which a manufacturer indicates that a device conforms to applicable EU requirements such as the MDR or IVDR.
Certification Body
An accredited third-party organization that audits and certifies management systems, such as ISO 13485 or ISO 9001.
Change Control
A documented process for evaluating, approving, implementing and verifying changes to products, processes or the QMS.
Clinical Data
Safety or performance information generated from the use of a device, from clinical investigations, published literature or post-market experience.
Clinical Evaluation
A planned, ongoing process of collecting, appraising and analyzing clinical data to verify a device’s safety, performance and clinical benefits.
Clinical Evaluation Report (CER)
The document that records the clinical evaluation and its conclusions on safety, performance and benefit-risk.
Clinical Investigation
A systematic investigation involving human subjects, undertaken to assess the safety or performance of a device.
Combination Product
A product made up of two or more regulated components, such as a drug and a device, combined into a single entity or packaged together.
Competent Authority
A national government body responsible for regulating medical devices or medicines within its jurisdiction.
Complaint
Any written, electronic or oral communication alleging deficiencies in the identity, quality, durability, reliability, safety or performance of a released product.
Conformity Assessment
The process demonstrating that a device meets the applicable regulatory requirements before it is placed on the market.
Contract Research Organization (CRO)
An organization contracted by a sponsor to perform one or more trial-related duties and functions.
Correction
Action taken to eliminate a detected nonconformity, as distinct from action addressing its cause.
Corrective Action
Action taken to eliminate the cause of a detected nonconformity and prevent it from happening again.
Cost of Quality
The total cost of preventing, appraising and correcting quality problems, used to make the business case for improvement.
Custom-Made Device
A device made specifically according to a written prescription for the sole use of a particular patient.
Declaration of Conformity
A manufacturer’s formal statement that a device meets the applicable requirements and has completed the required conformity assessment.
Design and Development Planning
Planning that defines design stages, reviews, verification, validation, transfer activities and responsibilities for a new product.
Design Controls
The interrelated practices that turn user needs into a verified and validated design, including inputs, outputs, reviews, verification, validation, transfer and changes.
Design History File (DHF)
A compilation of records describing the design history of a finished device.
Device Classification
Assignment of a device to a risk-based class, which determines the regulatory controls and route to market.
Device Master Record (DMR)
A compilation of records containing the procedures and specifications for a finished device. Under ISO 13485 the equivalent is the medical device file.
Distributor
Any person in the supply chain, other than the manufacturer or importer, who makes a device available on the market.
Document Control
The controls that ensure documents are reviewed, approved, current, available where needed and protected from unintended use.
Economic Operator
Under EU rules, a manufacturer, authorized representative, importer or distributor.
Establishment Registration
The annual registration that owners and operators of device establishments must complete with FDA.
EUDAMED
The European database on medical devices, supporting registration, UDI, certificates, vigilance and market surveillance under the MDR and IVDR.
EU MDR
Regulation (EU) 2017/745, the European regulation governing medical devices placed on the EU market.
Falsified Device
A device with a false presentation of its identity, source or certificates. Unintentional noncompliance is not falsification.
Field Safety Corrective Action (FSCA)
Action taken by a manufacturer for technical or medical reasons to reduce the risk of a serious incident with a device already on the market.
Field Safety Notice (FSN)
A communication sent by a manufacturer to users or customers about a field safety corrective action.
FMEA
Failure Modes and Effects Analysis: a structured method to identify potential failure modes, their effects and causes, and prioritize controls.
Gap Analysis
A comparison of current processes and documentation against a target standard or regulation to identify what needs to change.
Good Clinical Practice (GCP)
An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical studies.
Good Manufacturing Practice (GMP)
Practices that ensure products are consistently produced and controlled to quality standards appropriate to their intended use.
Harm
Injury or damage to people’s health, or damage to property or the environment.
Hazard
A potential source of harm.
Health Canada
The Canadian federal department that regulates medical devices, including Medical Device Licences and Medical Device Establishment Licences.
Implantable Device
A device intended to be wholly or partially introduced into the body and to remain there after the procedure.
Importer
A legal entity established in a market that places a device from another country on that market.
Incident
Any malfunction, deterioration in performance or inadequacy in labelling of a marketed device, including use errors linked to ergonomics.
Instructions for Use (IFU)
Information provided by the manufacturer that tells the user the device’s intended purpose, correct use and precautions.
Intended Purpose
The use for which a device is intended, as stated by the manufacturer in labelling, instructions, promotional material and the clinical evaluation.
Internal Audit
An audit carried out by, or on behalf of, an organization on its own QMS to confirm conformity and effectiveness.
Investigational Device Exemption (IDE)
FDA approval that allows an investigational device to be used in a clinical study to collect safety and effectiveness data.
In Vitro Diagnostic Device (IVD)
A device used to examine specimens taken from the human body, such as blood or tissue, to provide diagnostic or monitoring information.
ISO/IEC 17025
The international standard for the competence of testing and calibration laboratories.
ISO 9001
The international standard for quality management systems, applicable to organizations of any type and size.
ISO 13485
The international standard specifying quality management system requirements for organizations involved in the medical device life cycle.
ISO 14001
The international standard for environmental management systems.
ISO 14155
The international standard for good clinical practice in clinical investigations of medical devices.
ISO 14971
The international standard for applying risk management to medical devices.
ISO 19011
Guidelines for auditing management systems, covering audit programs, conduct and auditor competence.
ISO 45001
The international standard for occupational health and safety management systems.
Label
Written, printed or graphic information appearing on the device itself, its packaging or the packaging of multiple devices.
Labelling
All labels and other written, printed or graphic material that accompanies a device, including instructions for use.
Life Cycle
All phases in the life of a device, from initial concept to final decommissioning and disposal.
Management Review
Planned review by top management of the QMS to ensure its continuing suitability, adequacy and effectiveness.
Manufacturer
The person or organization responsible for designing and/or manufacturing a device and placing it on the market under its own name.
Market Surveillance
Activities carried out by authorities to check that devices on the market comply with requirements and do not endanger health or safety.
MDSAP
Medical Device Single Audit Program: one audit of a manufacturer’s QMS that satisfies the requirements of multiple participating regulators.
Medical Device
Any instrument, apparatus, software, implant, reagent, material or other article intended by its manufacturer for a medical purpose in humans.
Medical Device Establishment Licence (MDEL)
A Health Canada licence required to import or distribute medical devices in Canada.
Medical Device Licence (MDL)
A Health Canada licence required to sell Class II, III or IV medical devices in Canada.
MHRA
The Medicines and Healthcare products Regulatory Agency, which regulates medicines and medical devices in the United Kingdom.
Nonconformity
Non-fulfilment of a requirement. Audit findings are often graded as major or minor nonconformities.
Notified Body
An organization designated by an EU member state to assess the conformity of certain devices before they are placed on the market.
Objective Evidence
Data supporting the existence or truth of something, obtained through observation, measurement, testing or records.
Observation
A documented audit or inspection finding describing a condition that may indicate noncompliance or a risk of it.
Post-Market Clinical Follow-up (PMCF)
A continuous process that proactively collects clinical data on a CE-marked device to update its clinical evaluation.
Post-Market Surveillance (PMS)
Systematic processes to collect and review experience from devices on the market and identify any need for corrective or preventive action.
Premarket Approval (PMA)
The FDA scientific and regulatory review required to evaluate the safety and effectiveness of most Class III devices.
Preventive Action
Action taken to eliminate the cause of a potential nonconformity so that it does not occur.
Process Validation
Establishing by objective evidence that a process consistently produces a result or product meeting predetermined requirements.
PRRC
Person Responsible for Regulatory Compliance: the qualified person EU manufacturers and authorized representatives must have available under MDR/IVDR Article 15.
Purchasing Controls
Controls ensuring purchased products and services conform to requirements, including supplier evaluation, selection and monitoring.
QMSR
The FDA Quality Management System Regulation (21 CFR Part 820), effective February 2, 2026, which incorporates ISO 13485:2016 by reference with additional U.S. requirements.
Quality Assurance
The part of quality management focused on providing confidence that quality requirements will be fulfilled.
Quality Management System (QMS)
The organizational structure, responsibilities, procedures, processes and resources used to direct and control an organization with regard to quality.
Quality Manual
A document describing the scope of the QMS, its processes and how they interact, and references to supporting procedures.
Quality Objective
A measurable quality-related result to be achieved, consistent with the quality policy.
Quality Policy
The overall intentions and direction of an organization related to quality, formally expressed by top management.
Reasonably Foreseeable Misuse
Use of a device in a way not intended by the manufacturer but which can result from readily predictable human behaviour.
Recall
Removal or correction of a marketed product that violates regulatory requirements or presents a risk.
Recall Classification
FDA’s ranking of recalls by hazard: Class I (reasonable probability of serious harm or death), Class II (temporary or reversible harm) and Class III (unlikely to cause harm).
Regulatory Strategy
A plan defining how a product will meet the regulatory requirements of its target markets, including classification, pathway and evidence.
Remediation
Bringing a QMS or product back into compliance by investigating gaps, implementing corrections and corrective actions, and verifying effectiveness.
Residual Risk
Risk remaining after risk control measures have been implemented.
Risk
The combination of the probability of occurrence of harm and the severity of that harm.
Risk Analysis
Systematic use of available information to identify hazards and to estimate the risk.
Risk Assessment
The overall process comprising risk analysis and risk evaluation.
Risk Control
The process in which decisions are made and measures implemented to reduce risks to, or maintain them within, specified levels.
Risk Evaluation
Comparing estimated risk against given risk criteria to determine its acceptability.
Risk Management
Systematic application of policies, procedures and practices to analyzing, evaluating, controlling and monitoring risk.
Risk Management File
The set of records and other documents produced by risk management for a device.
Root Cause Analysis
A structured investigation to identify the underlying cause of a problem so that effective corrective action can be taken.
Serious Incident
An incident that directly or indirectly led, might have led or might lead to death, serious deterioration in health, or a serious public health threat.
Single-Use Device
A device intended to be used on one individual during a single procedure.
SOP
Standard Operating Procedure: a controlled document describing how a specific activity is to be carried out.
Sponsor
The individual or organization that takes responsibility for initiating, managing and financing a clinical investigation.
State of the Art
The developed stage of technical capability at a given time, based on the relevant consolidated findings of science, technology and experience.
Supplier Audit
An audit of a supplier’s processes and controls to qualify or monitor its ability to consistently meet requirements.
Technical Documentation
The documentation demonstrating a device’s conformity with applicable requirements, such as the technical file required under the EU MDR or IVDR.
Therapeutic Goods Administration (TGA)
Australia’s regulator for medicines, medical devices and other therapeutic goods.
Traceability
The ability to trace the history, application or location of a product, component or record.
U.S. Agent
A person residing in the United States whom a foreign device establishment designates as its FDA communication contact.
Unique Device Identification (UDI)
A system of unique numeric or alphanumeric codes, made up of a device identifier and production identifier, that identifies devices through distribution and use.
Use Error
A user action, or lack of action, that leads to a different result than intended by the manufacturer or expected by the user.
Validation
Confirmation, through objective evidence, that the requirements for a specific intended use or application have been fulfilled.
Verification
Confirmation, through objective evidence, that specified requirements have been fulfilled.
Vigilance
The reporting and evaluation of serious incidents and field safety corrective actions for devices on the market.
Warning Letter
An FDA letter notifying a firm of significant regulatory violations and requesting prompt corrective action.
Withdrawal
Any measure that aims to prevent a device in the supply chain from being further made available on the market.
Work Instruction
A detailed, step-by-step document describing how to perform a specific task within a procedure.
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Quick reference
Common abbreviations
- AIMDD
- Active Implantable Medical Devices Directive
- ANSI
- American National Standards Institute
- ANVISA
- Brazilian Health Regulatory Agency
- BOM
- Bill of Materials
- BSI
- British Standards Institution
- CAPA
- Corrective and Preventive Action
- CBER
- Center for Biologics Evaluation and Research (FDA)
- CDER
- Center for Drug Evaluation and Research (FDA)
- CDRH
- Center for Devices and Radiological Health (FDA)
- CEN
- European Committee for Standardization
- CER
- Clinical Evaluation Report
- CFR
- Code of Federal Regulations
- cGMP
- Current Good Manufacturing Practice
- CMDR
- Canadian Medical Devices Regulations
- CoQ
- Cost of Quality
- CRO
- Contract Research Organization
- DHF
- Design History File
- DHR
- Device History Record
- DMR
- Device Master Record
- DoC
- Declaration of Conformity
- EEA
- European Economic Area
- EU
- European Union
- EUDAMED
- European Database on Medical Devices
- FDA
- U.S. Food and Drug Administration
- FMEA
- Failure Modes and Effects Analysis
- FSCA
- Field Safety Corrective Action
- FSN
- Field Safety Notice
- GCP
- Good Clinical Practice
- GMP
- Good Manufacturing Practice
- IDE
- Investigational Device Exemption
- IFU
- Instructions for Use
- IMDRF
- International Medical Device Regulators Forum
- IQ / OQ / PQ
- Installation, Operational and Performance Qualification
- IVD
- In Vitro Diagnostic
- IVDR
- In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
- MDD
- Medical Devices Directive 93/42/EEC
- MDEL
- Medical Device Establishment Licence
- MDL
- Medical Device Licence
- MDR
- Medical Device Regulation (EU) 2017/745, or Medical Device Reporting (FDA)
- MDSAP
- Medical Device Single Audit Program
- MHRA
- Medicines and Healthcare products Regulatory Agency
- NCR
- Nonconformance Report
- OAI
- Official Action Indicated
- PMA
- Premarket Approval
- PMCF
- Post-Market Clinical Follow-up
- PMDA
- Pharmaceuticals and Medical Devices Agency (Japan)
- PMS
- Post-Market Surveillance
- PRRC
- Person Responsible for Regulatory Compliance
- PSUR
- Periodic Safety Update Report
- QA
- Quality Assurance
- QC
- Quality Control
- QMS
- Quality Management System
- QMSR
- Quality Management System Regulation
- QSR
- Quality System Regulation (former 21 CFR 820)
- RA
- Regulatory Affairs
- SOP
- Standard Operating Procedure
- SSCP
- Summary of Safety and Clinical Performance
- STED
- Summary Technical Documentation
- TGA
- Therapeutic Goods Administration
- UDI
- Unique Device Identification
- VAI
- Voluntary Action Indicated
- WI
- Work Instruction
Definitions are simplified for general reference. Always refer to the current official standard, regulation or guidance for formal requirements.