--- title: "Categories - MedTech Terms" description: "Browse MedTech terminology by category: regulatory, cybersecurity, software & AI, quality & risk, standards, clinical, manufacturing, and post-market." lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Browse # Categories The MedTech vocabulary, organized into the domains that regulatory, quality, clinical, software, and commercial teams work in every day. [Regulatory 99 ](/categories/regulatory)[Quality & Risk 36 ](/categories/quality-and-risk)[Cybersecurity 60 ](/categories/cybersecurity)[Clinical & Trials 49 ](/categories/clinical-and-trials)[Standards 22 ](/categories/standards)[Software & AI 31 ](/categories/software-and-ai)[Manufacturing 22 ](/categories/manufacturing)[Post-Market 22 ](/categories/post-market)[Investment & Finance 38 ](/categories/investment-and-finance)[Market Segments 38 ](/categories/market-segments)[Reimbursement 36 ](/categories/reimbursement)[Commercialization 23 ](/categories/commercialization)[Industry Bodies 13 ](/categories/industry-bodies) ## [Regulatory](/categories/regulatory) FDA, EU MDR/IVDR, and global pathways for getting devices to market. 99 terms [Category page](/categories/regulatory) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [513(g) Request for Information(513(g)) ](/terms/513g) - [Abbreviated 510(k) ](/terms/abbreviated-510k) - [Accreditation Scheme for Conformity Assessment(ASCA) ](/terms/asca) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [AI Act Prohibited Practices ](/terms/ai-act-prohibited-practices) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) - [ANVISA(ANVISA) ](/terms/anvisa) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [Benefit-Risk Determination ](/terms/benefit-risk) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [CE Mark ](/terms/ce-mark) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [Class III Device ](/terms/class-iii) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Combination Product ](/terms/combination-product) - [Common Specifications(CS) ](/terms/common-specifications) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [Companion Diagnostic (IVDR)(CDx) ](/terms/ivdr-companion-diagnostic) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Device Master File(MAF) ](/terms/device-master-file) - [Device Reclassification Petition ](/terms/reclassification-petition) - [Electronic Instructions for Use(eIFU) ](/terms/eifu) - [Emergency Use Authorization(EUA) ](/terms/eua) - [eSTAR ](/terms/estar) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [EUDAMED ](/terms/eudamed) - [FDA Recognized Consensus Standards ](/terms/recognized-standards) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [General Controls ](/terms/general-controls) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Health Canada Medical Device Licence(MDL) ](/terms/health-canada-mdl) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [Humanitarian Device Exemption(HDE) ](/terms/hde) - [IMDRF ](/terms/imdrf) - [Importer and Distributor Obligations (EU) ](/terms/importer-distributor) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Indications for Use(IFU (statement)) ](/terms/indications-for-use) - [Instructions for Use(IFU) ](/terms/ifu) - [Intended Use ](/terms/intended-use) - [ISO 20916 ](/terms/iso-20916) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [Labeling ](/terms/labeling) - [Letter to File(LTF) ](/terms/letter-to-file) - [MDR Article 117 ](/terms/mdr-article-117) - [Medical Device Coordination Group Guidance(MDCG) ](/terms/mdcg) - [Medical Device User Fee Amendments(MDUFA) ](/terms/mdufa) - [Metrological Traceability (IVDR) ](/terms/ivdr-metrological-traceability) - [MHRA / UKCA Marking(MHRA / UKCA) ](/terms/mhra-ukca) - [Ministry of Food and Drug Safety (Korea)(MFDS) ](/terms/mfds) - [Modular PMA ](/terms/pma-modular) - [National Medical Products Administration(NMPA) ](/terms/nmpa) - [NMPA Innovative Medical Device Pathway ](/terms/nmpa-innovation) - [Notified Body(NB) ](/terms/notified-body) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Pharmaceuticals and Medical Devices Agency(PMDA) ](/terms/pmda) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Predicate Device ](/terms/predicate-device) - [Premarket Approval(PMA) ](/terms/pma) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Refuse to Accept(RTA) ](/terms/rta) - [Request for Designation(RFD) ](/terms/rfd) - [Safer Technologies Program(STeP) ](/terms/step) - [Saudi Food and Drug Authority(SFDA) ](/terms/sfda) - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Self-Test and Near-Patient Testing (IVDR) ](/terms/ivdr-self-test) - [Special 510(k)(Special 510(k)) ](/terms/special-510k) - [Special Controls ](/terms/special-controls) - [Substantial Equivalence(SE) ](/terms/substantial-equivalence) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [Swissmedic ](/terms/swissmedic) - [Systemic Risk (GPAI) ](/terms/ai-act-systemic-risk) - [Therapeutic Goods Administration(TGA) ](/terms/tga) - [Third-Party Review of 510(k)(3P 510(k)) ](/terms/third-party-510k) - [UK Responsible Person(UKRP) ](/terms/ukrp) - [Unique Device Identification(UDI) ](/terms/udi) - [WHO Prequalification (Diagnostics)(WHO PQ Dx) ](/terms/who-pq-dx) ## [Quality & Risk](/categories/quality-and-risk) QMS, risk management, and process controls for medical devices. 36 terms [Category page](/categories/quality-and-risk) - [Biocompatibility ](/terms/biocompatibility) - [CAPA Effectiveness Check ](/terms/capa-effectiveness) - [Change Control ](/terms/change-control) - [Complaint Handling ](/terms/complaint-handling) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Design Controls ](/terms/design-controls) - [Design History File(DHF) ](/terms/design-history-file) - [Document Control ](/terms/document-control) - [Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [Fault Tree Analysis(FTA) ](/terms/fta) - [FDA Form 483 ](/terms/form-483) - [Hazard, Hazardous Situation, and Harm ](/terms/hazard-vs-harm) - [Internal Audit ](/terms/internal-audit) - [IQ / OQ / PQ ](/terms/iq-oq-pq) - [ISO 31000 ](/terms/iso-31000) - [Management Representative ](/terms/management-representative) - [Management Review ](/terms/management-review) - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [Nonconformance (NCR)(NCR) ](/terms/nonconformance) - [Post-Production Information (Risk) ](/terms/post-production-info) - [Process FMEA vs Design FMEA(PFMEA / DFMEA) ](/terms/pfmea-vs-dfmea) - [Production and Process Controls ](/terms/production-process-controls) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Quality Manual ](/terms/quality-manual) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Risk Acceptability Matrix ](/terms/risk-acceptability-matrix) - [Risk Management File(RMF) ](/terms/risk-management-file) - [Servicing (21 CFR 820.200) ](/terms/servicing) - [Shelf Life ](/terms/shelf-life) - [Summative vs. Formative Evaluation ](/terms/summative-formative) - [Training Records ](/terms/training-records) - [Use Specification ](/terms/use-specification) - [Use-Related Risk Analysis(URRA) ](/terms/urra) - [Validation Master Plan(VMP) ](/terms/validation-master-plan) - [Verification & Validation(V&V) ](/terms/verification-validation) - [Warning Letter ](/terms/warning-letter) ## [Cybersecurity](/categories/cybersecurity) Threat modeling, SBOMs, and secure-by-design for connected devices. 60 terms [Category page](/categories/cybersecurity) - [AAMI SW96 ](/terms/aami-sw96) - [AAMI TIR57 ](/terms/aami-tir57) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [Brainjacking ](/terms/brainjacking) - [CISA Known Exploited Vulnerabilities Catalog(KEV) ](/terms/kev) - [Code Signing ](/terms/code-signing) - [Common Vulnerabilities and Exposures(CVE) ](/terms/cve) - [Common Vulnerability Scoring System(CVSS) ](/terms/cvss) - [Common Weakness Enumeration(CWE) ](/terms/cwe) - [Coordinated Vulnerability Disclosure(CVD) ](/terms/cvd) - [Cryptographic Agility ](/terms/crypto-agility) - [CycloneDX ](/terms/cyclonedx) - [De-Identification of Health Data ](/terms/de-identification) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [Hardcoded Credentials ](/terms/hardcoded-credentials) - [Hardware Root of Trust(HRoT) ](/terms/hardware-root-of-trust) - [Health Industry Cybersecurity Practices(HICP) ](/terms/hicp) - [Health Information Sharing and Analysis Center(H-ISAC) ](/terms/h-isac) - [Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG) ](/terms/hph-cpg) - [HIPAA(HIPAA) ](/terms/hipaa) - [HITECH Act(HITECH) ](/terms/hitech-act) - [HITRUST CSF(HITRUST) ](/terms/hitrust) - [HSCC Joint Security Plan(HSCC JSP) ](/terms/hscc-jsp) - [ICS Medical Advisory(ICSMA) ](/terms/ics-medical-advisory) - [IEC 80001-1 ](/terms/iec-80001) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) - [IMDRF Principles and Practices for Medical Device Cybersecurity ](/terms/imdrf-cyber-principles) - [ISO/IEC 27001(ISO 27001) ](/terms/iso-27001) - [Legacy Device Cybersecurity ](/terms/legacy-device-cyber) - [LINDDUN ](/terms/linddun) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) - [Medhacking ](/terms/medhacking) - [Medjacking ](/terms/medjacking) - [MITRE ATT&CK(ATT&CK) ](/terms/mitre-attack) - [MITRE D3FEND(D3FEND) ](/terms/mitre-d3fend) - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473) ](/terms/nist-cswp-35) - [NIST SP 800-53 / 800-171(NIST 800-53/171) ](/terms/nist-800-53) - [Over-the-Air Updates(OTA) ](/terms/ota-updates) - [OWASP IoT and Embedded Application Security ](/terms/owasp-iot) - [Patchability ](/terms/patchability) - [Penetration Testing ](/terms/pen-test) - [PHI and ePHI ](/terms/phi-ephi) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Refuse to Accept (Cybersecurity)(RTA (cyber)) ](/terms/rta-cyber) - [SAST and DAST ](/terms/sast-dast) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Secure Boot ](/terms/secure-boot) - [Secure Product Development Framework(SPDF) ](/terms/spdf) - [Secure Software Development Framework(SSDF) ](/terms/ssdf) - [Side-Channel Attack ](/terms/side-channel) - [SOC 2 ](/terms/soc-2) - [Software Bill of Materials(SBOM) ](/terms/sbom) - [Software Safety Case ](/terms/software-safety-case) - [SPDX(SPDX) ](/terms/spdx) - [STRIDE Threat Model(STRIDE) ](/terms/stride) - [Supply-chain Levels for Software Artifacts(SLSA) ](/terms/slsa) - [Threat Modeling ](/terms/threat-modeling) - [Vulnerability Exploitability eXchange(VEX) ](/terms/vex) - [Zero Trust Architecture(ZTA) ](/terms/zero-trust) ## [Clinical & Trials](/categories/clinical-and-trials) Clinical evidence, investigations, and human-factors studies. 49 terms [Category page](/categories/clinical-and-trials) - [Adaptive Trial Design ](/terms/adaptive-trial) - [Adverse Event(AE) ](/terms/adverse-event) - [ALCOA+ ](/terms/alcoa-plus) - [Analytical Sensitivity ](/terms/analytical-sensitivity) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Blinding and Masking ](/terms/blinding) - [Case Report Form(CRF) ](/terms/case-report-form) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Clinical Evaluation Report(CER) ](/terms/cer) - [Clinical Investigation Plan(CIP) ](/terms/cip) - [Composite Endpoint ](/terms/composite-endpoint) - [Data Safety Monitoring Board(DSMB) ](/terms/dsmb) - [Decentralized Clinical Trial(DCT) ](/terms/decentralized-clinical-trial) - [Early Feasibility Study(EFS) ](/terms/efs) - [Electronic Data Capture(EDC) ](/terms/edc) - [Feasibility Study ](/terms/feasibility-study) - [First-in-Human Study(FIH) ](/terms/fih) - [Human Factors Engineering(HFE) ](/terms/human-factors) - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [IDE Supplement ](/terms/ide-supplement) - [Informed Consent ](/terms/informed-consent) - [Institutional Review Board(IRB) ](/terms/irb) - [Intent-to-Treat vs Per-Protocol(ITT / PP) ](/terms/itt-pp) - [Investigational Device Exemption(IDE) ](/terms/ide) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Limit of Detection / Limit of Quantitation(LoD / LoQ) ](/terms/lod-loq) - [Lost to Follow-up ](/terms/lost-to-followup) - [Master Protocol (Basket / Umbrella / Platform) ](/terms/master-protocol) - [Minimal Clinically Important Difference(MCID) ](/terms/mcid) - [Non-Inferiority Trial ](/terms/non-inferiority-trial) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Pivotal Trial ](/terms/pivotal-trial) - [Pragmatic Trial ](/terms/pragmatic-trial) - [Primary and Secondary Endpoints ](/terms/primary-secondary-endpoint) - [Propensity Score Methods ](/terms/propensity-score) - [Protocol Deviation ](/terms/protocol-deviation) - [Real-World Data(RWD) ](/terms/rwd) - [Real-World Evidence(RWE) ](/terms/real-world-evidence) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Sample Size and Statistical Power ](/terms/sample-size-power) - [Serious Adverse Event(SAE) ](/terms/sae) - [Sham Control ](/terms/sham-control) - [Source Data Verification(SDV) ](/terms/sdv) - [Surrogate Endpoint ](/terms/surrogate-endpoint) - [Trial Master File(TMF) ](/terms/trial-master-file) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [Use Error ](/terms/use-error) ## [Standards](/categories/standards) ISO, IEC, AAMI, and other consensus standards used by regulators. 22 terms [Category page](/categories/standards) - [ASTM F2503 ](/terms/astm-f2503) - [Essential Performance ](/terms/essential-performance) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [IEC 60601-1 ](/terms/iec-60601-1) - [IEC 60601-1-2 ](/terms/iec-60601-1-2) - [IEC 60825 ](/terms/iec-60825) - [IEC 62304 ](/terms/iec-62304) - [IEC 62366-1 ](/terms/iec-62366-1) - [IEC 82304-1 ](/terms/iec-82304-1) - [ISO 10993-1 ](/terms/iso-10993-1) - [ISO 11135 ](/terms/iso-11135) - [ISO 11137 ](/terms/iso-11137) - [ISO 11607-1/-2 ](/terms/iso-11607) - [ISO 13485 ](/terms/iso-13485) - [ISO 14155 ](/terms/iso-14155) - [ISO 14971 ](/terms/iso-14971) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) - [ISO 17665 ](/terms/iso-17665) - [ISO 20417 ](/terms/iso-20417) - [ISO 22301 ](/terms/iso-22301) - [ISO/IEC 23894 ](/terms/iso-iec-23894) - [ISO/TR 24971 ](/terms/tr24971) ## [Software & AI](/categories/software-and-ai) SaMD, SiMD, AI/ML models, and software lifecycle terminology. 31 terms [Category page](/categories/software-and-ai) - [AAMI TIR45(TIR45) ](/terms/aami-tir45) - [Adversarial Robustness ](/terms/adversarial-robustness) - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) - [Clinical Decision Support(CDS) ](/terms/cds) - [Data Governance (AI/ML) ](/terms/data-governance) - [Datasheets for Datasets ](/terms/datasheets-for-datasets) - [EU AI Act ](/terms/eu-ai-act) - [Explainability and Interpretability ](/terms/explainability) - [Federated Learning ](/terms/federated-learning) - [Foundation Model (Healthcare) ](/terms/foundation-model-health) - [Generative AI in Medical Devices ](/terms/generative-ai-devices) - [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) - [Interoperability ](/terms/interoperability) - [Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive) - [Medical Device Data System(MDDS) ](/terms/mdds) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Model Card ](/terms/model-card) - [Model Drift Monitoring ](/terms/drift-monitoring) - [ONC HTI-1 / HTI-2 ](/terms/onc-hti) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [Predetermined Maintenance vs PCCP ](/terms/predetermined-maintenance) - [Secure-by-Design (Devices) ](/terms/secure-by-design) - [Software as a Medical Device(SaMD) ](/terms/samd) - [Software in a Medical Device(SiMD) ](/terms/simd) - [Software Maintenance Plan ](/terms/software-maintenance-plan) - [Software of Unknown Provenance(SOUP) ](/terms/soup) - [Software Safety Classification ](/terms/software-safety-class) - [Synthetic Data ](/terms/synthetic-data) - [Total Product Lifecycle(TPLC) ](/terms/tplc) ## [Manufacturing](/categories/manufacturing) Design transfer, production controls, and supply chain terms. 22 terms [Category page](/categories/manufacturing) - [Bill of Materials(BOM) ](/terms/bom) - [Bioburden ](/terms/bioburden) - [Cleanroom Classes (ISO 14644) ](/terms/cleanroom-iso-14644) - [Container Closure Integrity(CCI) ](/terms/container-closure) - [Counterfeit Parts and Suspect Components ](/terms/counterfeit-parts) - [Design Transfer ](/terms/design-transfer) - [Device History Record(DHR) ](/terms/dhr) - [Device Master Record(DMR) ](/terms/dmr) - [Endotoxin Testing (LAL) ](/terms/endotoxin) - [Engineering Change Order / Notice(ECO / ECN) ](/terms/eco-ecn) - [Lot Traceability ](/terms/lot-traceability) - [MRP and ERP Systems(MRP / ERP) ](/terms/mrp-erp) - [Pre-Approval Inspection(PAI) ](/terms/pai) - [Process Capability (Cp/Cpk) and SPC ](/terms/spc-cpk) - [Process Capability and Cpk ](/terms/process-capability-cpk) - [Process Validation ](/terms/process-validation) - [Scrap Rate and Yield ](/terms/scrap-yield) - [Stability Testing ](/terms/stability-testing) - [Sterilization ](/terms/sterilization) - [Supplier Controls ](/terms/supplier-controls) - [Technology Transfer (Manufacturing) ](/terms/tech-transfer) - [UDI-DI vs. UDI-PI ](/terms/udi-di-pi) ## [Post-Market](/categories/post-market) Surveillance, vigilance, recalls, and lifecycle management. 22 terms [Category page](/categories/post-market) - [5-Day Report ](/terms/five-day-report) - [Annual Report (PMA) ](/terms/annual-report-pma) - [Customer Notification Letter ](/terms/customer-notification) - [Electronic Medical Device Reporting(eMDR) ](/terms/emdr) - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Field Action vs Recall ](/terms/field-action-vs-recall) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) - [Global Unique Device Identification Database(GUDID) ](/terms/gudid) - [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval) - [Manufacturer Incident Report(MIR) ](/terms/mir) - [Medical Device Recall ](/terms/recall) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [Medical Device Vigilance ](/terms/vigilance) - [Periodic Safety Update Report(PSUR) ](/terms/psur) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Post-Market Surveillance Plan ](/terms/pms-plan) - [PSUR (IVDR Specific) ](/terms/psur-ivdr) - [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction) - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [Trend Reporting (MDR/MIR) ](/terms/trend-reporting) ## [Investment & Finance](/categories/investment-and-finance) Venture financing, term sheets, valuation, and capital structure for MedTech startups. 38 terms [Category page](/categories/investment-and-finance) - [409A Valuation ](/terms/409a-valuation) - [Anti-Dilution Protection ](/terms/anti-dilution) - [Bridge Round ](/terms/bridge-round) - [Burn Rate ](/terms/burn-rate) - [Burn Rate and Runway ](/terms/burn-runway) - [Capitalization Table(Cap Table) ](/terms/cap-table) - [Convertible Note ](/terms/convertible-note) - [Dilution ](/terms/dilution) - [Down Round ](/terms/down-round) - [Drag-Along and Tag-Along Rights ](/terms/drag-tag-along) - [Due Diligence ](/terms/due-diligence) - [Earn-Out ](/terms/earn-out) - [Employee Option Pool ](/terms/option-pool) - [Exit Multiple ](/terms/exit-multiple) - [Initial Public Offering(IPO) ](/terms/ipo) - [Limited Partner / General Partner(LP / GP) ](/terms/lp-gp) - [Liquidation Preference ](/terms/liquidation-preference) - [Liquidity Event ](/terms/liquidity-event) - [Mergers and Acquisitions(M&A) ](/terms/m-and-a) - [Milestone Payment ](/terms/milestone-payment) - [Milestone-Based Tranche ](/terms/milestone-tranche) - [Non-Dilutive Funding ](/terms/non-dilutive-funding) - [Post-Money Valuation ](/terms/post-money-valuation) - [Pre-Money Valuation ](/terms/pre-money-valuation) - [Preferred Stock ](/terms/preferred-stock) - [Pro-Rata Rights ](/terms/pro-rata-rights) - [Royalty Financing ](/terms/royalty-financing) - [Runway ](/terms/runway) - [SBIR / STTR Grants(SBIR/STTR) ](/terms/sbir-sttr) - [Series A / B / C Financing Rounds ](/terms/series-funding) - [Simple Agreement for Future Equity(SAFE) ](/terms/safe-note) - [Special Purpose Acquisition Company(SPAC) ](/terms/spac) - [Strategic Investor ](/terms/strategic-investor) - [Term Sheet ](/terms/term-sheet) - [Tranched Financing ](/terms/tranched-financing) - [Valuation Cap ](/terms/valuation-cap) - [Venture Debt ](/terms/venture-debt) - [Vesting Schedule ](/terms/vesting) ## [Market Segments](/categories/market-segments) Therapeutic and technology segments - cardiovascular, IVD, surgical robotics, DTx, and more. 38 terms [Category page](/categories/market-segments) - [Aesthetic & Energy-Based Devices ](/terms/aesthetics-energy-devices) - [AI Imaging Software ](/terms/ai-imaging) - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Cardiovascular Devices ](/terms/cardiovascular) - [Clinical Laboratory Improvement Amendments(CLIA) ](/terms/clia) - [Companion Diagnostic(CDx) ](/terms/companion-diagnostic) - [Dental Devices ](/terms/dental-devices) - [Diabetes Care ](/terms/diabetes-care) - [Digital Therapeutic(DTx) ](/terms/samd-dtx) - [Digital Therapeutics(DTx) ](/terms/digital-therapeutics) - [Drug Delivery Devices ](/terms/drug-delivery-devices) - [Electrophysiology(EP) ](/terms/electrophysiology) - [Endoscopy Devices ](/terms/endoscopy-devices) - [ENT Devices ](/terms/ent-devices) - [Hearing Devices ](/terms/hearing-devices) - [In Vitro Diagnostics(IVD) ](/terms/ivd) - [In Vitro Diagnostics (Segment)(IVD) ](/terms/ivd-segment) - [Laboratory-Developed Test(LDT) ](/terms/ldt) - [Medical Imaging ](/terms/medical-imaging) - [Molecular Diagnostics ](/terms/molecular-diagnostics) - [Neuromodulation ](/terms/neuromodulation) - [Ophthalmology Devices ](/terms/ophthalmology-devices) - [Orthopedic Devices ](/terms/orthopedics) - [Patient Monitoring ](/terms/patient-monitoring) - [Point-of-Care Diagnostics(POC) ](/terms/point-of-care) - [Remote Patient Monitoring(RPM) ](/terms/remote-patient-monitoring) - [Renal Care Devices ](/terms/renal-care-devices) - [Respiratory Devices ](/terms/respiratory-devices) - [Single-Use Device(SUD) ](/terms/single-use-device) - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Spine ](/terms/spine) - [Structural Heart ](/terms/structural-heart) - [Surgical Robotics ](/terms/surgical-robotics) - [Urology Devices ](/terms/urology-devices) - [Wearable Medical Devices ](/terms/wearables) - [Wearables and Remote Patient Monitoring(RPM) ](/terms/wearables-rpm) - [Women's Health Devices ](/terms/womens-health) - [Wound Care ](/terms/wound-care) ## [Reimbursement](/categories/reimbursement) Coding, coverage, and payment pathways across CMS, commercial payers, and global HTAs. 36 terms [Category page](/categories/reimbursement) - [340B Drug Pricing Program(340B) ](/terms/340b) - [Ambulatory Payment Classification(APC) ](/terms/apc) - [ASC Site-of-Service Shift ](/terms/asc-shift) - [Budget Impact Model(BIM) ](/terms/budget-impact-model) - [Bundled Payment ](/terms/bundled-payment) - [Category III CPT Code ](/terms/category-iii-cpt) - [Category III CPT Codes ](/terms/category-iii-codes) - [CMS IDE Coverage (Category A & B) ](/terms/ide-coverage) - [Coverage with Evidence Development(CED) ](/terms/ced) - [CPT Codes(CPT) ](/terms/cpt-codes) - [Current Procedural Terminology Codes(CPT) ](/terms/cpt) - [Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS) ](/terms/dmepos) - [HCPCS Codes(HCPCS) ](/terms/hcpcs) - [Health Economics and Outcomes Research(HEOR) ](/terms/heor) - [Health Technology Assessment(HTA) ](/terms/hta) - [ICD-10-CM / ICD-10-PCS ](/terms/icd-10) - [Incremental Cost-Effectiveness Ratio(ICER) ](/terms/icer) - [Inpatient Prospective Payment System(IPPS) ](/terms/ipps) - [Joint Clinical Assessment(JCA) ](/terms/jca) - [LCD and NCD ](/terms/lcd-ncd) - [Medicare Administrative Contractor(MAC) ](/terms/mac) - [Medicare Physician Fee Schedule(MPFS) ](/terms/physician-fee-schedule) - [MS-DRG(MS-DRG) ](/terms/ms-drg) - [National and Local Coverage Determinations(NCD / LCD) ](/terms/ncd-lcd) - [New Technology Add-On Payment(NTAP) ](/terms/ntap) - [Outpatient Prospective Payment System(OPPS) ](/terms/opps) - [Prior Authorization ](/terms/prior-authorization) - [Proprietary Laboratory Analyses Codes(PLA) ](/terms/pla-codes) - [Protecting Access to Medicare Act(PAMA) ](/terms/pama) - [Quality-Adjusted Life Year(QALY) ](/terms/qaly) - [Recovery Audit Contractor(RAC) ](/terms/rac-audit) - [RWE for Reimbursement ](/terms/real-world-evidence-reimbursement) - [Site-Neutral Payment ](/terms/site-neutral-payment) - [Transitional Coverage for Emerging Technologies(TCET) ](/terms/tcet) - [Transitional Pass-Through Payment(TPT) ](/terms/tpt) - [Value-Based Care(VBC) ](/terms/value-based-care) ## [Commercialization](/categories/commercialization) Go-to-market, sales channels, KOLs, and hospital purchasing dynamics. 23 terms [Category page](/categories/commercialization) - [AdvaMed Code of Ethics ](/terms/advamed-code) - [Advisory Board ](/terms/advisory-board) - [Anti-Kickback Statute(AKS) ](/terms/anti-kickback) - [Bottom-Up Market Sizing ](/terms/bottom-up-sizing) - [Distributor vs Direct Sales ](/terms/distributor-direct) - [Field Clinical Engineer(FCE) ](/terms/field-clinical-engineer) - [Freedom to Operate(FTO) ](/terms/freedom-to-operate) - [Good Clinical Practice(GCP) ](/terms/gcp) - [Group Purchasing Organization(GPO) ](/terms/gpo) - [Integrated Delivery Network(IDN) ](/terms/idn) - [Key Opinion Leader(KOL) ](/terms/kol) - [Label Claims ](/terms/label-claims) - [Launch Readiness ](/terms/launch-readiness) - [Managed Service / Reagent Rental ](/terms/managed-service-contract) - [Off-Label Use ](/terms/off-label-use) - [Physician Payments Sunshine Act ](/terms/sunshine-act) - [Physician Training and Proctoring ](/terms/training-and-proctoring) - [Pre-Submission Meeting(Q-Sub) ](/terms/pre-submission) - [Razor / Razor-Blade Model ](/terms/razor-razorblade) - [Stark Law ](/terms/stark-law) - [Strategic Acquisition ](/terms/acquisition) - [TAM / SAM / SOM ](/terms/tam-sam-som) - [Value Analysis Committee(VAC) ](/terms/vac) ## [Industry Bodies](/categories/industry-bodies) Vendor-neutral trade associations, standards-setting organizations, professional societies, public-private consortia, and non-commercial accelerator programs. 13 terms [Category page](/categories/industry-bodies) - [AAMI(AAMI) ](/terms/aami) - [AdvaMed ](/terms/advamed) - [AdvaMedDx ](/terms/advameddx) - [Contract Research Organization(CRO) ](/terms/cro) - [Corporate Venture Capital(CVC) ](/terms/corporate-venture) - [Fogarty Innovation ](/terms/fogarty-innovation) - [Industry Trade Organizations ](/terms/industry-orgs) - [Medical Device Innovation Consortium(MDIC) ](/terms/mdic) - [MedTech Accelerators and Incubators ](/terms/accelerator-MedTech) - [MedTech Innovator ](/terms/medtech-innovator) - [Regulatory Affairs Professionals Society(RAPS) ](/terms/raps) - [Specialty MedTech Venture Capital ](/terms/specialty-medtech-vc) - [Texas Medical Center Innovation(TMC Innovation) ](/terms/texas-medical-center) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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