510(k)
Definition: An FDA premarket submission proving that a new device is substantially equivalent in safety and effectiveness to a legally marketed predicate device.
Example: Submitting a 510(k) for a new glucose meter similar to those already approved.

Note: Canadian equivalent submissions are not called 510(k) but follow medical device licensing via Health Canada
See also: FDA, De Novo Classification, Premarket Approval (PMA)
Keywords: FDA 510k submission, medical device FDA clearance

21 CFR Part 820
Definition: FDA regulation (Quality System Regulation, QSR) outlining current good manufacturing practices (cGMP) for medical devices marketed in the U.S.
Example: US device manufacturers must design, document, and manufacture products in compliance with 21 CFR Part 820.
See also: FDA Audit, QMS, ISO 13485
Keywords: 21 CFR 820, FDA QSR, medical device cGMP

Adverse Event
Definition: Any unexpected or harmful occurrence involving a medical device.
Example: Reporting a patient’s allergic reaction to Health Canada during postmarket surveillance.
See also: Complaint Handling, FSCA, Postmarket Surveillance, Health Canada Reporting, FDA Reporting, MDR Reporting
Keywords: medical device adverse event, device safety reporting

Audit Response
Definition: A comprehensive written reply to regulatory bodies or auditors addressing observations, nonconformities, or deficiencies identified during an audit.
Example: Submitting an audit response to address FDA 483 observations, outlining remedial actions and CAPA plans.
See also: FDA Inspection, Internal Auditing, CAPA
Keywords: audit response letter, regulatory audit response

CAPA (Corrective and Preventive Action)
Definition: A structured approach to investigating and resolving nonconformities and preventing recurrence.
Example: Documenting root cause analysis and corrective steps for repeated process failures.
See also: CAPA Program, NCR, QMS
Keywords: medical device CAPA, corrective action, preventive action

CAPA Program
Definition: The organizational system managing all CAPA activities, including tracking, trending, and analyzing quality events.
Example: An electronic CAPA program provides company-wide visibility over all quality issues and responses.
See also: CAPA, QMS, Internal Auditing
Keywords: CAPA management software, FDA CAPA system

CE Marking
Definition: Certification indicating compliance with essential EU health, safety, and performance standards under EU MDR.
Example: A bone fixation device requires CE Marking and notified body review before launching in Germany.
See also: EU MDR, Notified Body, Technical File
Keywords: CE marking medical device, EU compliance

Clinical Evaluation Report (CER)
Definition: A document demonstrating conformity with EU MDR safety and performance requirements via clinical data analysis.
Example: A CER supports life-cycle management and annual updates for a long-term implant.
See also: Technical Documentation for EU MDR Certification, EU MDR
Keywords: clinical evaluation report, EU MDR CER

Complaint Handling
Definition: Documented receipt, review, investigation, and resolution of complaints per QMS and regulatory requirements.
Example: Promptly investigating a customer-reported device malfunction per FDA/ISO requirements.
See also: Adverse Event, CAPA, Postmarket Surveillance
Keywords: medical device complaint handling

Corrective Actions
Definition: Actions taken to eliminate the root cause of a detected nonconformity.
Example: Repairing a packaging process and retraining staff after device contamination issues.
See also: CAPA, Remediation Plan, Internal Auditing
Keywords: corrective action plan, CAPA corrections

De Novo Classification
Definition: FDA process for classifying novel, low- to moderate-risk devices lacking a predicate.
Example: A new digital diagnostic tool qualified via De Novo after 510(k) pathway was deemed unsuitable.
See also: 510(k), FDA
Keywords: FDA De Novo, novel medical device pathway

Design Controls
Definition: Processes ensuring devices meet user needs, intended uses, and regulatory requirements.
Example: Designing a user interface using human factors engineering and documenting each iteration.
See also: QMS, Human Factors Engineering
Keywords: FDA design controls, ISO 13485 design

Device History Record (DHR)
Definition: Detailed batch/lot records demonstrating device manufactured per DMR and procedures.
Example: FDA inspection includes review of DHRs for traceability and process control.
See also: DMR, QMS
Keywords: device history record, FDA DHR

Device Master Record (DMR)
Definition: Compilation of instructions, drawings, and procedures required for manufacturing a medical device.
Example: Every change in test protocol must be reflected in DMR updates.
See also: DHR, Technical File
Keywords: device master record, DMR

Due Diligence
Definition: Comprehensive review to assess regulatory, quality, and business risks before mergers, acquisitions, or investments.
Example: RegPro Medical conducts due diligence audits prior to client acquisition of a device startup.
See also: Regulatory Affairs, Audit Response
Keywords: medical device due diligence, QMS consulting

EU MDR (Medical Device Regulation)
Definition: The EU’s regulatory framework enforcing strict controls on device safety, performance, and clinical evaluation.
Example: A legacy device required extensive documentation updates to conform with EU MDR.
See also: CE Marking, Technical Documentation for EU MDR Certification
Keywords: EU MDR, medical device Europe

European Authorized Representative
Definition: A legally appointed entity within the EU acting on behalf of non-EU manufacturers to fulfill regulatory obligations.
Example: A US or Canadian device manufacturer appoints an EU authorized representative to handle complaints and communication with authorities.
See also: CE Marking, EU MDR
Keywords: European authorized representative, EU mandates

FDA (Food and Drug Administration)
Definition: U.S. agency overseeing development, manufacture, and marketing of medical devices. 
Example: FDA inspection checks conformity with 21 CFR Part 820 and product safety.
See also: 510(k), FDA Audit, FDA Warning Letter
Keywords: FDA medical devices, FDA regulations

FDA Audit
Definition: On-site or remote review by FDA to assess compliance with regulatory requirements.
Example: An FDA audit may result in Form 483 observations, leading to CAPA.
See also: Internal Auditing, Audit Response, FDA Inspection
Keywords: FDA audit preparation, FDA site inspection

FDA Inspection
Definition: Comprehensive examination by FDA, often triggered by complaints, regulatory changes, or pre-approval reviews.
Example: FDA inspection reveals gaps in complaint handling and CAPA management.
See also: FDA Audit, FDA Warning Letter
Keywords: FDA inspection checklist

FDA Warning Letter
Definition: Formal notification from FDA identifying serious violations found during inspections or file reviews.
Example: A firm receives a warning letter for inadequate CAPA documentation.
See also: CAPA, Remediation Plan
Keywords: FDA warning letter response, regulatory compliance

Field Safety Corrective Action (FSCA)
Definition: Actions taken to mitigate risk or correct a device issue in the field—includes recalls and safety notices.
Example: Issuing an urgent field safety notice due to a battery defect.
See also: Recall, Complaint Handling
Keywords: field safety corrective action, device recall

GMP (Good Manufacturing Practice)
Definition International standards ensuring production is consistently controlled and regulated.
Example: GMP-certified facility monitors raw materials, process controls, and staff training.
See also: ISO 13485, QMS
Keywords: GMP medical device, manufacturing standards

Human Factors Engineering
Definition: Discipline focused on designing devices to optimize human use, minimize errors, and enhance usability and safety.
Example: Human factors validation required for new diagnostic systems under FDA guidance.
See also: Usability Engineering, IEC 62366, Design Controls
Keywords: human factors medical device, usability testing, user experience safety

IEC 62366
Definition: International standard specifying requirements for applying usability engineering to medical devices.
Example: Manufacturers use IEC 62366 to structure usability testing and documentation for home-use devices.
See also: Usability Engineering, Human Factors Engineering
Keywords: IEC 62366, usability standard medical device

Internal Auditing
Definition: Routine audits performed by or for an organization to assess QMS effectiveness and compliance with standards (e.g., ISO 13485).
Example: Quarterly internal audits drive continuous QMS improvement.
See also: Audit Response, CAPA, QMS Process Refinement
Keywords: internal audit medical device, ISO 13485 audit

ISO 10993-1
Definition: International standard for assessing medical device biocompatibility, including evaluation and testing of cytotoxicity, sensitization, and irritation.
Example: ISO 10993-1 testing is required for all new skin-contacting devices sold in the EU or US.

See also: Validation, Technical File
Keywords: ISO 10993-1, biocompatibility

ISO 11135
Definition: Standard for validation and routine control of ethylene oxide sterilization for medical devices.
Example: Sterilization contract manufacturers rely on ISO 11135 validation data for FDA submissions.
See also: Sterility Validation, Process Validation
Keywords: ISO 11135, EO sterilization validation

ISO 11137-1
Definition: Requirements for the development, validation, and routine control of radiation sterilization processes.
Example: ISO 11137-1 is relevant for single-use disposable device manufacturers.
See also: Sterility Validation, Validation
Keywords: ISO 11137-1, radiation sterilization

ISO 11607-1
Definition: Standard describing requirements for packaging materials, sterile barrier systems, and packaging validation.
Example: Packaging for surgical kits must be validated and documented per ISO 11607-1.
See also: Process Validation, Shelf Life Validation
Keywords: ISO 11607-1, sterile packaging validation

ISO 13485
Definition: Quality management system standard specific to medical device design, development, and manufacture.
Example: Achieving ISO 13485 certification is essential for global market entry.
See also: QMS, Internal Auditing
Keywords: ISO 13485 certification, QMS requirements

ISO 14971
Definition: Widely accepted standard for risk management throughout the medical device lifecycle.
Example: All devices marketed in Europe require documented risk management per ISO 14971.
See also: Risk Management, QMS
Keywords: ISO 14971, risk assessment medical device

Labeling
Definition: All identification, use instructions, warnings, and claims provided with a device.
Example: Updates to device IFU following incident reports are part of regulatory compliance.
See also: FDA, Technical File
Keywords: medical device labeling

Management Review
Definition: Systematic meetings where top management evaluates QMS effectiveness and compliance.
Example: Quarterly management reviews check if CAPA and audit findings are addressed.
See also: QMS, QMS Process Refinement
Keywords: management review ISO 13485

MDSAP (Medical Device Single Audit Program)

Definition: Audit program permitting a single quality audit recognized by multiple jurisdictions (US, Canada, Australia, Brazil, Japan).
Example: A RegPro Medical client leverages MDSAP to streamline global regulatory audits.
See also: Audit Response, Internal Auditing
Keywords: MDSAP, international device compliance

Nonconformity / Non-Conformance Report (NCR)
Definition: A record of any deviation from specified requirements in product or process.
Example: An NCR may lead to a CAPA for process improvements.
See also: CAPA, Internal Auditing
Keywords: NCR, nonconformity

Notified Body
Definition: EU-designated organization authorized to assess device conformity prior to CE Marking.
Example: A notified body audits technical files and QMS for Class III devices.
See also: CE Marking, EU MDR
Keywords: EU notified body

Postmarket Surveillance
Definition: Systematic monitoring of device performance and safety after commercial launch.
Example: Postmarket data triggers design modifications for safety improvement.
See also: Adverse Event, FSCA
Keywords: postmarket surveillance plan

Premarket Approval (PMA)
Definition: FDA's most stringent marketing review process for high-risk devices.
Example: Securing PMA involved clinical trial data and manufacturing audits.
See also: 510(k), FDA

Keywords: FDA PMA, class III device

Process Validation
Definition: Documented evidence confirming that a production process consistently yields products meeting predetermined specifications.
Example: Validating a sterilization cycle for single-use catheters.
See also: Validation, ISO 11135, ISO 11137-1
Keywords: process validation medical device, FDA process validation

QMS (Quality Management System)
Definition: All policies, procedures, records, and processes ensuring device quality and compliance.
Example: Implementing QMS software accelerates document control and audit prep.
See also: ISO 13485, QMS Process Refinement
Keywords: quality management systems, QMS medical device

QMS Process Refinement
Definition: Continuous improvement cycle applied to QMS policies and practices to maintain regulatory compliance and effectiveness.
Example: Regular review and streamlining of CAPA tracking to reduce closure times.
See also: Management Review, Internal Auditing
Keywords: QMS optimization, quality system improvement

Quality Assurance (QA)
Definition: Processes ensuring products meet quality regulations throughout design, development, and manufacture.
Example: QA oversees manufacturing controls, training, and documentation.
See also: Quality Control (QC), QMS
Keywords: quality assurance medical device

Quality Control (QC)
Definition: Methods and activities used to verify product conformity to specifications.
Example: QC checks include final product inspections and testing.
See also: QA, Validation
Keywords: quality control QC, device QC procedures

Recall
Definition: Action to remove, correct, or notify users of marketed devices violating law or posing risk.
Example: Voluntary recall for labeling errors affecting patient safety.
See also: FSCA, Postmarket Surveillance
Keywords: medical device recall

Regulatory Affairs
Definition: Professionals managing regulatory submissions, compliance, and interaction with agencies.
Example: RegPro Medical’s RA team prepares worldwide device registrations and labeling reviews.
See also: Regulatory Strategy, Due Diligence
Keywords: regulatory affairs, regulatory compliance

Regulatory Strategy
Definition: Planned approach for global regulatory submissions, approvals, and lifecycle management.
Example: Developing an integrated FDA and CE Marking strategy to minimize time-to-market.
See also: Regulatory Affairs, CE Marking
Keywords: regulatory strategy medical device

Remediation Plan
Definition: Structured plan to remedy regulatory findings, usually after audit or warning letter.
Example: Implementing process remediation after an FDA warning letter for documentation gaps.
See also: CAPA, Audit Response
Keywords: remediation plan, compliance remediation

Risk Management / ISO 14971
Definition: Systematic process for risk assessment, mitigation, and monitoring throughout a device lifecycle.
Example: Risk management files prepared for each design project per ISO 14971.
See also: QMS, ISO 14971
Keywords: device risk management

SaMD (Software as a Medical Device)
Definition: Standalone software intended for medical purposes.
Example: Machine learning-based diagnostic tools for smartphones.
See also: FDA, Validation

Keywords: SaMD, regulatory software medical device

Shelf Life Validation
Definition: Testing and documented evidence ensuring device stability, packaging integrity, and performance throughout intended shelf life.
Example: A sterile wound dressing passes accelerated aging and shelf life validation.
See also: ISO 11607-1, Process Validation
Keywords: shelf life validation, product stability

Sterility Validation
Definition: Studies and records confirming devices are reliably sterile at release.
Example: Sterility validation for single-use syringes includes biological indicators and process verification.
See also: ISO 11135, Process Validation, Validation
Keywords: sterility validation, sterile medical device

Supplier Qualification
Definition: Evaluation and monitoring of suppliers to meet quality and regulatory demands.
Example: Approved supplier list compiled after on-site audits and capability assessments.
See also: QMS, Audit
Keywords: supplier qualification, approved supplier program

Technical Documentation for EU MDR Certification
Definition: Full collection of device design, risk analysis, clinical data, manufacturing, labeling, and performance data—required for MDR CE Marking.
Example: RegPro Medical assembles technical documentation to meet notified body review standards.
See also: Technical File, EU MDR
Keywords: EU MDR technical documentation, MDR certification

Technical File / Documentation
Definition: Dossier of technical and regulatory documentation demonstrating conformity and supporting market authorization.
Example: Inclusion of biocompatibility, usability, and risk management summaries in the technical file.
See also: CE Marking, Notified Body
Keywords: technical documentation medical device

UDI (Unique Device Identification)
Definition: Distinct alphanumeric codes for identifying and tracking medical devices.
Example: Implantable devices are labeled and registered under FDA and EU UDI databases.
See also: FDA, Postmarket Surveillance
Keywords: UDI, traceability

Usability Engineering
Definition: Systematic application of user interface design principles to medical devices, as required by IEC 62366.
Example: Usability testing for an insulin pump ensures users can set up and dose without error.
See also: Human Factors Engineering, IEC 62366, Design Controls
Keywords: usability engineering, medical device usability studies

Validation
Definition: Evidence (documented studies or tests) proving devices, processes, or systems consistently meet predetermined requirements.
Example: Software validation ensures a diagnostic app performs accurately before release.
See also: Process Validation, Verification
Keywords: validation protocol, validated process

Verification
Definition: Assessment confirming products or processes meet defined specifications, usually by inspection, testing, or analysis.
Example: Prototype units undergo verification testing to ensure all design outputs are met.

See also: Validation, Design Controls
Keywords: device verification, verification testing

This glossary is continually updated for regulatory changes.

For expert medical device regulatory consulting email consulting@RegProMedical.com or call George Lane +1 (425) 241 - 3092