--- title: "Changelog - MedTech Terms updates" description: "A running log of new and reviewed MedTech terms across regulatory, cybersecurity, quality, software, clinical, and standards categories." lang: en json-ld: | { "@context": "https://schema.org", "@type": "CollectionPage", "@id": "https://medtechterms.com/changelog#page", "name": "MedTech Terms Changelog", "description": "Chronological log of MedTech term additions and reviews, updated as regulations, standards, and guidance evolve.", "url": "https://medtechterms.com/changelog", "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "dateModified": "2026-07-25" } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Updated daily # Changelog Every review, revision, and new term - dated. We track sources across FDA, EU MDR/IVDR, ISO, IEC, IMDRF, and other primary authorities, and stamp each entry when we last verified it. **489** terms tracked Latest review: **July 25, 2026** [How we review terms](/methodology) 1. ## July 25, 2026 34 terms reviewed - [High-Risk AI System (EU AI Act) Regulatory ](/terms/ai-act-high-risk-system) - [General-Purpose AI Model(GPAI) Regulatory ](/terms/ai-act-gpai) - [Systemic Risk (GPAI) Regulatory ](/terms/ai-act-systemic-risk) - [Provider and Deployer (EU AI Act) Regulatory ](/terms/ai-act-provider-deployer) - [AI Act Conformity Assessment (Medical Devices) Regulatory ](/terms/ai-act-conformity-assessment) - [AI Act Technical Documentation (Annex IV) Regulatory ](/terms/ai-act-technical-documentation) - [AI Act Post-Market Monitoring Regulatory ](/terms/ai-act-post-market-monitoring) - [AI Act Serious Incident Reporting Regulatory ](/terms/ai-act-serious-incident-reporting) - [AI Act Transparency Obligations Regulatory ](/terms/ai-act-transparency-obligations) - [Fundamental Rights Impact Assessment(FRIA) Regulatory ](/terms/ai-act-fria) - [AI Act Prohibited Practices Regulatory ](/terms/ai-act-prohibited-practices) - [IVDR Performance Evaluation Regulatory ](/terms/ivdr-performance-evaluation) - [Scientific Validity (IVDR) Regulatory ](/terms/ivdr-scientific-validity) - [Analytical Performance (IVDR) Regulatory ](/terms/ivdr-analytical-performance) - [Clinical Performance (IVDR) Regulatory ](/terms/ivdr-clinical-performance) - [Performance Study (IVDR) Clinical & Trials ](/terms/ivdr-performance-study) - [Post-Market Performance Follow-up(PMPF) Post-Market ](/terms/pmpf) - [In-House IVDs (Article 5(5)) Regulatory ](/terms/ivdr-in-house-devices) - [IVDR Legacy Device Regulatory ](/terms/ivdr-legacy-device) - [EU Reference Laboratory (EURL)(EURL) Regulatory ](/terms/ivdr-eu-reference-laboratory) - [Self-Test and Near-Patient Testing (IVDR) Regulatory ](/terms/ivdr-self-test) - [Summary of Safety and Performance (IVDR)(SSP) Regulatory ](/terms/ivdr-summary-safety-performance) - [Companion Diagnostic (IVDR)(CDx) Regulatory ](/terms/ivdr-companion-diagnostic) - [Common Specifications (IVDR)(CS) Regulatory ](/terms/ivdr-common-specifications) - [IVDR Conformity Assessment Routes Regulatory ](/terms/ivdr-conformity-assessment-routes) - [Class D Batch Verification (IVDR) Regulatory ](/terms/ivdr-class-d-batch-verification) - [IVDR Transitional Provisions Regulatory ](/terms/ivdr-transitional-provisions) - [General Safety and Performance Requirements (IVDR)(GSPR) Regulatory ](/terms/ivdr-gspr) - [Notified Body Scrutiny (IVDR Class D) Regulatory ](/terms/ivdr-notified-body-scrutiny) - [Genetic Testing Requirements (IVDR Article 4) Regulatory ](/terms/ivdr-genetic-testing) - [Performance Study Application (IVDR) Regulatory ](/terms/ivdr-performance-study-application) - [Metrological Traceability (IVDR) Regulatory ](/terms/ivdr-metrological-traceability) - [Post-Market Surveillance Plan (IVDR) Regulatory ](/terms/ivdr-pms-plan) - [Post-Market Performance Follow-Up (IVDR)(PMPF) Regulatory ](/terms/ivdr-pmpf) 2. ## June 20, 2026 40 terms reviewed - [CISA Known Exploited Vulnerabilities Catalog(KEV) Cybersecurity ](/terms/kev) - [MITRE ATT&CK(ATT&CK) Cybersecurity ](/terms/mitre-attack) - [MITRE D3FEND(D3FEND) Cybersecurity ](/terms/mitre-d3fend) - [Common Weakness Enumeration(CWE) Cybersecurity ](/terms/cwe) - [Health Industry Cybersecurity Practices(HICP) Cybersecurity ](/terms/hicp) - [Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG) Cybersecurity ](/terms/hph-cpg) - [Health Information Sharing and Analysis Center(H-ISAC) Cybersecurity ](/terms/h-isac) - [AAMI TIR97(TIR97) Cybersecurity ](/terms/aami-tir97) - [Secure Software Development Framework(SSDF) Cybersecurity ](/terms/ssdf) - [Supply-chain Levels for Software Artifacts(SLSA) Cybersecurity ](/terms/slsa) - [Code Signing Cybersecurity ](/terms/code-signing) - [Hardware Root of Trust(HRoT) Cybersecurity ](/terms/hardware-root-of-trust) - [LINDDUN Cybersecurity ](/terms/linddun) - [SOC 2 Cybersecurity ](/terms/soc-2) - [HITRUST CSF(HITRUST) Cybersecurity ](/terms/hitrust) - [FedRAMP(FedRAMP) Cybersecurity ](/terms/fedramp) - [ICS Medical Advisory(ICSMA) Cybersecurity ](/terms/ics-medical-advisory) - [NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473) Cybersecurity ](/terms/nist-cswp-35) - [Emergency Use Authorization(EUA) Regulatory ](/terms/eua) - [Device Master File(MAF) Regulatory ](/terms/device-master-file) - [Section 522 Postmarket Surveillance(Section 522) Post-Market ](/terms/section-522) - [510(k) Summary vs 510(k) Statement Regulatory ](/terms/510k-summary-vs-statement) - [Modular PMA Regulatory ](/terms/pma-modular) - [Real-Time PMA Supplement Review Regulatory ](/terms/pma-real-time-review) - [PMA Supplement Types Regulatory ](/terms/pma-supplement-types) - [Device Reclassification Petition Regulatory ](/terms/reclassification-petition) - [Additional Condition for Nonprescription Use(ACNU) Regulatory ](/terms/acnu) - [Real-World Data(RWD) Clinical & Trials ](/terms/rwd) - [Unanticipated Adverse Device Effect(UADE) Clinical & Trials ](/terms/uade) - [Investigator Brochure(IB) Clinical & Trials ](/terms/investigator-brochure) - [Electronic Data Capture(EDC) Clinical & Trials ](/terms/edc) - [Risk-Based Monitoring(RBM) Clinical & Trials ](/terms/risk-based-monitoring) - [ICH E6(R3) Good Clinical Practice(E6(R3)) Standards ](/terms/ich-e6-r3) - [Clinical Evaluation Plan(CEP) Clinical & Trials ](/terms/clinical-evaluation-plan) - [IDE Annual Progress Report Clinical & Trials ](/terms/ide-annual-report) - [Medical Device Data System(MDDS) Software & AI ](/terms/mdds) - [Algorithm Change Protocol(ACP) Software & AI ](/terms/algorithm-change-protocol) - [AAMI TIR45(TIR45) Software & AI ](/terms/aami-tir45) - [Datasheets for Datasets Software & AI ](/terms/datasheets-for-datasets) - [MLOps for Medical Devices(MLOps) Software & AI ](/terms/mlops-medical-device) 3. ## May 9, 2026 37 terms reviewed - [Cardiac Rhythm Management(CRM) Market Segments ](/terms/cardiac-rhythm-management) - [Endoscopy Devices Market Segments ](/terms/endoscopy-devices) - [Urology Devices Market Segments ](/terms/urology-devices) - [Dental Devices Market Segments ](/terms/dental-devices) - [Hearing Devices Market Segments ](/terms/hearing-devices) - [Patient Monitoring Market Segments ](/terms/patient-monitoring) - [Sleep & Respiratory Devices Market Segments ](/terms/sleep-respiratory-devices) - [Aesthetic & Energy-Based Devices Market Segments ](/terms/aesthetics-energy-devices) - [Single-Use Device(SUD) Market Segments ](/terms/single-use-device) - [Renal Care Devices Market Segments ](/terms/renal-care-devices) - [Ambulatory Payment Classification(APC) Reimbursement ](/terms/apc) - [Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS) Reimbursement ](/terms/dmepos) - [Medicare Administrative Contractor(MAC) Reimbursement ](/terms/mac) - [Proprietary Laboratory Analyses Codes(PLA) Reimbursement ](/terms/pla-codes) - [Site-Neutral Payment Reimbursement ](/terms/site-neutral-payment) - [Health Economics and Outcomes Research(HEOR) Reimbursement ](/terms/heor) - [Budget Impact Model(BIM) Reimbursement ](/terms/budget-impact-model) - [CMS IDE Coverage (Category A & B) Reimbursement ](/terms/ide-coverage) - [Series A / B / C Financing Rounds Investment & Finance ](/terms/series-funding) - [Limited Partner / General Partner(LP / GP) Investment & Finance ](/terms/lp-gp) - [Initial Public Offering(IPO) Investment & Finance ](/terms/ipo) - [Mergers and Acquisitions(M&A) Investment & Finance ](/terms/m-and-a) - [Earn-Out Investment & Finance ](/terms/earn-out) - [Special Purpose Acquisition Company(SPAC) Investment & Finance ](/terms/spac) - [409A Valuation Investment & Finance ](/terms/409a-valuation) - [Drag-Along and Tag-Along Rights Investment & Finance ](/terms/drag-tag-along) - [Royalty Financing Investment & Finance ](/terms/royalty-financing) - [Liquidity Event Investment & Finance ](/terms/liquidity-event) - [Non-Inferiority Trial Clinical & Trials ](/terms/non-inferiority-trial) - [Sample Size and Statistical Power Clinical & Trials ](/terms/sample-size-power) - [Decentralized Clinical Trial(DCT) Clinical & Trials ](/terms/decentralized-clinical-trial) - [Trial Master File(TMF) Clinical & Trials ](/terms/trial-master-file) - [Case Report Form(CRF) Clinical & Trials ](/terms/case-report-form) - [Investigator-Initiated Trial(IIT) Clinical & Trials ](/terms/investigator-initiated-trial) - [Master Protocol (Basket / Umbrella / Platform) Clinical & Trials ](/terms/master-protocol) - [Pragmatic Trial Clinical & Trials ](/terms/pragmatic-trial) - [Primary and Secondary Endpoints Clinical & Trials ](/terms/primary-secondary-endpoint) 4. ## May 5, 2026 378 terms reviewed - [510(k) Premarket Notification(510(k)) Regulatory ](/terms/510k) - [Premarket Approval(PMA) Regulatory ](/terms/pma) - [De Novo Classification Request(De Novo) Regulatory ](/terms/de-novo) - [Substantial Equivalence(SE) Regulatory ](/terms/substantial-equivalence) - [Predicate Device Regulatory ](/terms/predicate-device) - [Quality System Regulation(QSR / 21 CFR 820) Quality & Risk ](/terms/qsr) - [Quality Management System Regulation(QMSR) Quality & Risk ](/terms/qmsr) - [ISO 13485 Standards ](/terms/iso-13485) - [ISO 14971 Standards ](/terms/iso-14971) - [ISO/TR 24971 Standards ](/terms/tr24971) - [IEC 62304 Standards ](/terms/iec-62304) - [Software Safety Classification Software & AI ](/terms/software-safety-class) - [IEC 62366-1 Standards ](/terms/iec-62366-1) - [IEC 60601-1 Standards ](/terms/iec-60601-1) - [Essential Performance Standards ](/terms/essential-performance) - [IEC 60601-1-2 Standards ](/terms/iec-60601-1-2) - [ISO 10993-1 Standards ](/terms/iso-10993-1) - [Biocompatibility Quality & Risk ](/terms/biocompatibility) - [Software as a Medical Device(SaMD) Software & AI ](/terms/samd) - [Software in a Medical Device(SiMD) Software & AI ](/terms/simd) - [Clinical Decision Support(CDS) Software & AI ](/terms/cds) - [Refuse to Accept(RTA) Regulatory ](/terms/rta) - [Unique Device Identification(UDI) Regulatory ](/terms/udi) - [EU Medical Device Regulation(MDR) Regulatory ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) Regulatory ](/terms/ivdr) - [Notified Body(NB) Regulatory ](/terms/notified-body) - [CE Mark Regulatory ](/terms/ce-mark) - [EUDAMED Regulatory ](/terms/eudamed) - [Corrective and Preventive Action(CAPA) Quality & Risk ](/terms/capa) - [Nonconformance (NCR)(NCR) Quality & Risk ](/terms/nonconformance) - [Complaint Handling Quality & Risk ](/terms/complaint-handling) - [Design Controls Quality & Risk ](/terms/design-controls) - [Verification & Validation(V&V) Quality & Risk ](/terms/verification-validation) - [Design History File(DHF) Quality & Risk ](/terms/design-history-file) - [Device Master Record(DMR) Manufacturing ](/terms/dmr) - [Device History Record(DHR) Manufacturing ](/terms/dhr) - [Design Transfer Manufacturing ](/terms/design-transfer) - [Process Validation Manufacturing ](/terms/process-validation) - [Supplier Controls Manufacturing ](/terms/supplier-controls) - [Risk Management File(RMF) Quality & Risk ](/terms/risk-management-file) - [Benefit-Risk Determination Regulatory ](/terms/benefit-risk) - [Human Factors Engineering(HFE) Clinical & Trials ](/terms/human-factors) - [Use Error Clinical & Trials ](/terms/use-error) - [Post-Market Surveillance(PMS) Post-Market ](/terms/post-market-surveillance) - [Periodic Safety Update Report(PSUR) Post-Market ](/terms/psur) - [Medical Device Vigilance Post-Market ](/terms/vigilance) - [Field Safety Corrective Action(FSCA) Post-Market ](/terms/fsca) - [Medical Device Recall Post-Market ](/terms/recall) - [Medical Device Reporting (FDA)(MDR) Post-Market ](/terms/mdr-reporting) - [Predetermined Change Control Plan(PCCP) Software & AI ](/terms/ai-ml-pccp) - [Good Machine Learning Practice(GMLP) Software & AI ](/terms/good-machine-learning-practice) - [Software of Unknown Provenance(SOUP) Software & AI ](/terms/soup) - [Instructions for Use(IFU) Regulatory ](/terms/ifu) - [Labeling Regulatory ](/terms/labeling) - [Investigational Device Exemption(IDE) Clinical & Trials ](/terms/ide) - [Institutional Review Board(IRB) Clinical & Trials ](/terms/irb) - [Informed Consent Clinical & Trials ](/terms/informed-consent) - [ICH E6 Good Clinical Practice(GCP) Clinical & Trials ](/terms/ich-gcp) - [ISO 14155 Standards ](/terms/iso-14155) - [Class III Device Regulatory ](/terms/class-iii) - [Pre-Approval Inspection(PAI) Manufacturing ](/terms/pai) - [FDA Form 483 Quality & Risk ](/terms/form-483) - [Warning Letter Quality & Risk ](/terms/warning-letter) - [Intended Use Regulatory ](/terms/intended-use) - [Indications for Use(IFU (statement)) Regulatory ](/terms/indications-for-use) - [Interoperability Software & AI ](/terms/interoperability) - [Real-World Evidence(RWE) Clinical & Trials ](/terms/real-world-evidence) - [IMDRF Regulatory ](/terms/imdrf) - [Medical Device Single Audit Program(MDSAP) Quality & Risk ](/terms/mdsap) - [Sterilization Manufacturing ](/terms/sterilization) - [Shelf Life Quality & Risk ](/terms/shelf-life) - [Humanitarian Device Exemption(HDE) Regulatory ](/terms/hde) - [Breakthrough Device Designation(BDD) Regulatory ](/terms/breakthrough-device) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Regulatory ](/terms/q-sub) - [Safer Technologies Program(STeP) Regulatory ](/terms/step) - [Special 510(k)(Special 510(k)) Regulatory ](/terms/special-510k) - [Abbreviated 510(k) Regulatory ](/terms/abbreviated-510k) - [Combination Product Regulatory ](/terms/combination-product) - [Request for Designation(RFD) Regulatory ](/terms/rfd) - [eSTAR Regulatory ](/terms/estar) - [Letter to File(LTF) Regulatory ](/terms/letter-to-file) - [IDE Supplement Clinical & Trials ](/terms/ide-supplement) - [Pharmaceuticals and Medical Devices Agency(PMDA) Regulatory ](/terms/pmda) - [National Medical Products Administration(NMPA) Regulatory ](/terms/nmpa) - [Therapeutic Goods Administration(TGA) Regulatory ](/terms/tga) - [Health Canada Medical Device Licence(MDL) Regulatory ](/terms/health-canada-mdl) - [ANVISA(ANVISA) Regulatory ](/terms/anvisa) - [MHRA / UKCA Marking(MHRA / UKCA) Regulatory ](/terms/mhra-ukca) - [Ministry of Food and Drug Safety (Korea)(MFDS) Regulatory ](/terms/mfds) - [WHO Prequalification (Diagnostics)(WHO PQ Dx) Regulatory ](/terms/who-pq-dx) - [Clinical Evaluation Report(CER) Clinical & Trials ](/terms/cer) - [Post-Market Clinical Follow-up(PMCF) Post-Market ](/terms/pmcf) - [Summary of Safety and Clinical Performance(SSCP) Regulatory ](/terms/sscp) - [Adverse Event(AE) Clinical & Trials ](/terms/adverse-event) - [Serious Adverse Event(SAE) Clinical & Trials ](/terms/sae) - [Protocol Deviation Clinical & Trials ](/terms/protocol-deviation) - [ALCOA+ Clinical & Trials ](/terms/alcoa-plus) - [Source Data Verification(SDV) Clinical & Trials ](/terms/sdv) - [CAPA Effectiveness Check Quality & Risk ](/terms/capa-effectiveness) - [Management Review Quality & Risk ](/terms/management-review) - [Internal Audit Quality & Risk ](/terms/internal-audit) - [Document Control Quality & Risk ](/terms/document-control) - [Training Records Quality & Risk ](/terms/training-records) - [Hazard, Hazardous Situation, and Harm Quality & Risk ](/terms/hazard-vs-harm) - [Failure Mode and Effects Analysis(FMEA) Quality & Risk ](/terms/fmea) - [Fault Tree Analysis(FTA) Quality & Risk ](/terms/fta) - [AI/ML-Enabled Medical Device Software & AI ](/terms/ai-ml-device) - [Locked vs. Adaptive Algorithm Software & AI ](/terms/locked-vs-adaptive) - [Model Card Software & AI ](/terms/model-card) - [Algorithmic Bias and Fairness Software & AI ](/terms/ai-bias-fairness) - [Total Product Lifecycle(TPLC) Software & AI ](/terms/tplc) - [EU AI Act Software & AI ](/terms/eu-ai-act) - [ISO/IEC 23894 Standards ](/terms/iso-iec-23894) - [Analytical Sensitivity Clinical & Trials ](/terms/analytical-sensitivity) - [Limit of Detection / Limit of Quantitation(LoD / LoQ) Clinical & Trials ](/terms/lod-loq) - [IVDR Risk Classes A–D Regulatory ](/terms/ivdr-classes) - [Common Specifications(CS) Regulatory ](/terms/common-specifications) - [UDI-DI vs. UDI-PI Manufacturing ](/terms/udi-di-pi) - [Global Unique Device Identification Database(GUDID) Post-Market ](/terms/gudid) - [Process Capability (Cp/Cpk) and SPC Manufacturing ](/terms/spc-cpk) - [Stability Testing Manufacturing ](/terms/stability-testing) - [Change Control Quality & Risk ](/terms/change-control) - [FDA Recall Classifications I, II, III Post-Market ](/terms/recall-classifications) - [ISO 15223-1 Symbols Standards ](/terms/iso-15223-1) - [Electronic Instructions for Use(eIFU) Regulatory ](/terms/eifu) - [Use Specification Quality & Risk ](/terms/use-specification) - [Use-Related Risk Analysis(URRA) Quality & Risk ](/terms/urra) - [Summative vs. Formative Evaluation Quality & Risk ](/terms/summative-formative) - [Current Procedural Terminology Codes(CPT) Reimbursement ](/terms/cpt) - [Category III CPT Codes Reimbursement ](/terms/category-iii-codes) - [ICD-10-CM / ICD-10-PCS Reimbursement ](/terms/icd-10) - [National and Local Coverage Determinations(NCD / LCD) Reimbursement ](/terms/ncd-lcd) - [Coverage with Evidence Development(CED) Reimbursement ](/terms/ced) - [Transitional Coverage for Emerging Technologies(TCET) Reimbursement ](/terms/tcet) - [Value Analysis Committee(VAC) Commercialization ](/terms/vac) - [AdvaMed Code of Ethics Commercialization ](/terms/advamed-code) - [Tranched Financing Investment & Finance ](/terms/tranched-financing) - [Milestone Payment Investment & Finance ](/terms/milestone-payment) - [Burn Rate and Runway Investment & Finance ](/terms/burn-runway) - [Digital Therapeutic(DTx) Market Segments ](/terms/samd-dtx) - [Cardiovascular Devices Market Segments ](/terms/cardiovascular) - [In Vitro Diagnostics (Segment)(IVD) Market Segments ](/terms/ivd-segment) - [Wearables and Remote Patient Monitoring(RPM) Market Segments ](/terms/wearables-rpm) - [Specialty MedTech Venture Capital Industry Bodies ](/terms/specialty-medtech-vc) - [Corporate Venture Capital(CVC) Industry Bodies ](/terms/corporate-venture) - [Contract Research Organization(CRO) Industry Bodies ](/terms/cro) - [MedTech Accelerators and Incubators Industry Bodies ](/terms/accelerator-MedTech) - [Industry Trade Organizations Industry Bodies ](/terms/industry-orgs) - [Simple Agreement for Future Equity(SAFE) Investment & Finance ](/terms/safe-note) - [Convertible Note Investment & Finance ](/terms/convertible-note) - [Valuation Cap Investment & Finance ](/terms/valuation-cap) - [Term Sheet Investment & Finance ](/terms/term-sheet) - [Pre-Money Valuation Investment & Finance ](/terms/pre-money-valuation) - [Post-Money Valuation Investment & Finance ](/terms/post-money-valuation) - [Capitalization Table(Cap Table) Investment & Finance ](/terms/cap-table) - [Dilution Investment & Finance ](/terms/dilution) - [Liquidation Preference Investment & Finance ](/terms/liquidation-preference) - [Preferred Stock Investment & Finance ](/terms/preferred-stock) - [Anti-Dilution Protection Investment & Finance ](/terms/anti-dilution) - [Employee Option Pool Investment & Finance ](/terms/option-pool) - [Vesting Schedule Investment & Finance ](/terms/vesting) - [Runway Investment & Finance ](/terms/runway) - [Burn Rate Investment & Finance ](/terms/burn-rate) - [Milestone-Based Tranche Investment & Finance ](/terms/milestone-tranche) - [Pro-Rata Rights Investment & Finance ](/terms/pro-rata-rights) - [Down Round Investment & Finance ](/terms/down-round) - [Bridge Round Investment & Finance ](/terms/bridge-round) - [Strategic Investor Investment & Finance ](/terms/strategic-investor) - [Non-Dilutive Funding Investment & Finance ](/terms/non-dilutive-funding) - [SBIR / STTR Grants(SBIR/STTR) Investment & Finance ](/terms/sbir-sttr) - [Venture Debt Investment & Finance ](/terms/venture-debt) - [Exit Multiple Investment & Finance ](/terms/exit-multiple) - [Due Diligence Investment & Finance ](/terms/due-diligence) - [Structural Heart Market Segments ](/terms/structural-heart) - [Electrophysiology(EP) Market Segments ](/terms/electrophysiology) - [Orthopedic Devices Market Segments ](/terms/orthopedics) - [Spine Market Segments ](/terms/spine) - [Surgical Robotics Market Segments ](/terms/surgical-robotics) - [In Vitro Diagnostics(IVD) Market Segments ](/terms/ivd) - [Molecular Diagnostics Market Segments ](/terms/molecular-diagnostics) - [Companion Diagnostic(CDx) Market Segments ](/terms/companion-diagnostic) - [Laboratory-Developed Test(LDT) Market Segments ](/terms/ldt) - [Clinical Laboratory Improvement Amendments(CLIA) Market Segments ](/terms/clia) - [Point-of-Care Diagnostics(POC) Market Segments ](/terms/point-of-care) - [Neuromodulation Market Segments ](/terms/neuromodulation) - [Diabetes Care Market Segments ](/terms/diabetes-care) - [Wearable Medical Devices Market Segments ](/terms/wearables) - [Remote Patient Monitoring(RPM) Market Segments ](/terms/remote-patient-monitoring) - [Digital Therapeutics(DTx) Market Segments ](/terms/digital-therapeutics) - [Medical Imaging Market Segments ](/terms/medical-imaging) - [AI Imaging Software Market Segments ](/terms/ai-imaging) - [Ophthalmology Devices Market Segments ](/terms/ophthalmology-devices) - [ENT Devices Market Segments ](/terms/ent-devices) - [Women's Health Devices Market Segments ](/terms/womens-health) - [Wound Care Market Segments ](/terms/wound-care) - [Respiratory Devices Market Segments ](/terms/respiratory-devices) - [Drug Delivery Devices Market Segments ](/terms/drug-delivery-devices) - [CPT Codes(CPT) Reimbursement ](/terms/cpt-codes) - [Category III CPT Code Reimbursement ](/terms/category-iii-cpt) - [HCPCS Codes(HCPCS) Reimbursement ](/terms/hcpcs) - [MS-DRG(MS-DRG) Reimbursement ](/terms/ms-drg) - [Inpatient Prospective Payment System(IPPS) Reimbursement ](/terms/ipps) - [New Technology Add-On Payment(NTAP) Reimbursement ](/terms/ntap) - [Transitional Pass-Through Payment(TPT) Reimbursement ](/terms/tpt) - [Outpatient Prospective Payment System(OPPS) Reimbursement ](/terms/opps) - [ASC Site-of-Service Shift Reimbursement ](/terms/asc-shift) - [Medicare Physician Fee Schedule(MPFS) Reimbursement ](/terms/physician-fee-schedule) - [LCD and NCD Reimbursement ](/terms/lcd-ncd) - [Prior Authorization Reimbursement ](/terms/prior-authorization) - [Value-Based Care(VBC) Reimbursement ](/terms/value-based-care) - [Bundled Payment Reimbursement ](/terms/bundled-payment) - [Health Technology Assessment(HTA) Reimbursement ](/terms/hta) - [Joint Clinical Assessment(JCA) Reimbursement ](/terms/jca) - [Quality-Adjusted Life Year(QALY) Reimbursement ](/terms/qaly) - [Incremental Cost-Effectiveness Ratio(ICER) Reimbursement ](/terms/icer) - [RWE for Reimbursement Reimbursement ](/terms/real-world-evidence-reimbursement) - [Recovery Audit Contractor(RAC) Reimbursement ](/terms/rac-audit) - [340B Drug Pricing Program(340B) Reimbursement ](/terms/340b) - [Protecting Access to Medicare Act(PAMA) Reimbursement ](/terms/pama) - [Key Opinion Leader(KOL) Commercialization ](/terms/kol) - [Advisory Board Commercialization ](/terms/advisory-board) - [Physician Payments Sunshine Act Commercialization ](/terms/sunshine-act) - [Anti-Kickback Statute(AKS) Commercialization ](/terms/anti-kickback) - [Stark Law Commercialization ](/terms/stark-law) - [Group Purchasing Organization(GPO) Commercialization ](/terms/gpo) - [Integrated Delivery Network(IDN) Commercialization ](/terms/idn) - [Good Clinical Practice(GCP) Commercialization ](/terms/gcp) - [Pre-Submission Meeting(Q-Sub) Commercialization ](/terms/pre-submission) - [Field Clinical Engineer(FCE) Commercialization ](/terms/field-clinical-engineer) - [Razor / Razor-Blade Model Commercialization ](/terms/razor-razorblade) - [Managed Service / Reagent Rental Commercialization ](/terms/managed-service-contract) - [TAM / SAM / SOM Commercialization ](/terms/tam-sam-som) - [Bottom-Up Market Sizing Commercialization ](/terms/bottom-up-sizing) - [Freedom to Operate(FTO) Commercialization ](/terms/freedom-to-operate) - [Label Claims Commercialization ](/terms/label-claims) - [Off-Label Use Commercialization ](/terms/off-label-use) - [Launch Readiness Commercialization ](/terms/launch-readiness) - [Physician Training and Proctoring Commercialization ](/terms/training-and-proctoring) - [Distributor vs Direct Sales Commercialization ](/terms/distributor-direct) - [Strategic Acquisition Commercialization ](/terms/acquisition) - [AdvaMed Industry Bodies ](/terms/advamed) - [AdvaMedDx Industry Bodies ](/terms/advameddx) - [Medical Device Innovation Consortium(MDIC) Industry Bodies ](/terms/mdic) - [Regulatory Affairs Professionals Society(RAPS) Industry Bodies ](/terms/raps) - [AAMI(AAMI) Industry Bodies ](/terms/aami) - [MedTech Innovator Industry Bodies ](/terms/medtech-innovator) - [Texas Medical Center Innovation(TMC Innovation) Industry Bodies ](/terms/texas-medical-center) - [Fogarty Innovation Industry Bodies ](/terms/fogarty-innovation) - [513(g) Request for Information(513(g)) Regulatory ](/terms/513g) - [General Controls Regulatory ](/terms/general-controls) - [Special Controls Regulatory ](/terms/special-controls) - [FDA Recognized Consensus Standards Regulatory ](/terms/recognized-standards) - [Accreditation Scheme for Conformity Assessment(ASCA) Regulatory ](/terms/asca) - [Third-Party Review of 510(k)(3P 510(k)) Regulatory ](/terms/third-party-510k) - [Medical Device User Fee Amendments(MDUFA) Regulatory ](/terms/mdufa) - [MDR Article 117 Regulatory ](/terms/mdr-article-117) - [General Safety and Performance Requirements(GSPRs) Regulatory ](/terms/gspr) - [Person Responsible for Regulatory Compliance(PRRC) Regulatory ](/terms/prrc) - 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[Clinical Investigation Plan(CIP) Clinical & Trials ](/terms/cip) - [ISO 11607-1/-2 Standards ](/terms/iso-11607) - [ISO 11135 Standards ](/terms/iso-11135) - [ISO 11137 Standards ](/terms/iso-11137) - [ISO 17665 Standards ](/terms/iso-17665) - [ISO 20417 Standards ](/terms/iso-20417) - [ISO 22301 Standards ](/terms/iso-22301) - [IEC 60825 Standards ](/terms/iec-60825) - [IEC 82304-1 Standards ](/terms/iec-82304-1) - [ASTM F2503 Standards ](/terms/astm-f2503) - [Cleanroom Classes (ISO 14644) Manufacturing ](/terms/cleanroom-iso-14644) - [Bioburden Manufacturing ](/terms/bioburden) - [Endotoxin Testing (LAL) Manufacturing ](/terms/endotoxin) - [Container Closure Integrity(CCI) Manufacturing ](/terms/container-closure) - [Technology Transfer (Manufacturing) Manufacturing ](/terms/tech-transfer) - [Engineering Change Order / Notice(ECO / ECN) Manufacturing ](/terms/eco-ecn) - [Bill of Materials(BOM) Manufacturing ](/terms/bom) - [MRP and ERP Systems(MRP / ERP) Manufacturing ](/terms/mrp-erp) - [Lot Traceability Manufacturing ](/terms/lot-traceability) - [Scrap Rate and Yield Manufacturing ](/terms/scrap-yield) - [Counterfeit Parts and Suspect Components Manufacturing ](/terms/counterfeit-parts) - [Process Capability and Cpk Manufacturing ](/terms/process-capability-cpk) - [Trend Reporting (MDR/MIR) Post-Market ](/terms/trend-reporting) - [5-Day Report Post-Market ](/terms/five-day-report) - [Manufacturer Incident Report(MIR) Post-Market ](/terms/mir) - [Field Action vs Recall Post-Market ](/terms/field-action-vs-recall) - [Removal vs Correction (21 CFR 806) Post-Market ](/terms/removal-vs-correction) - [Customer Notification Letter Post-Market ](/terms/customer-notification) - [Health Hazard Evaluation(HHE) Post-Market ](/terms/health-hazard-eval) - [Annual Report (PMA) Post-Market ](/terms/annual-report-pma) - [Electronic Medical Device Reporting(eMDR) Post-Market ](/terms/emdr) - [PSUR (IVDR Specific) Post-Market ](/terms/psur-ivdr) - [Post-Market Surveillance Plan Post-Market ](/terms/pms-plan) - [Software Bill of Materials(SBOM) Cybersecurity ](/terms/sbom) - [Section 524B of the FD&C Act(524B) Cybersecurity ](/terms/section-524b) - [Premarket Cybersecurity Submission Cybersecurity ](/terms/premarket-cybersecurity) - [Secure Product Development Framework(SPDF) Cybersecurity ](/terms/spdf) - [Threat Modeling Cybersecurity ](/terms/threat-modeling) - [STRIDE Threat Model(STRIDE) Cybersecurity ](/terms/stride) - [Common Vulnerabilities and Exposures(CVE) Cybersecurity ](/terms/cve) - [Common Vulnerability Scoring System(CVSS) Cybersecurity ](/terms/cvss) - [Vulnerability Exploitability eXchange(VEX) Cybersecurity ](/terms/vex) - [SPDX(SPDX) Cybersecurity ](/terms/spdx) - [CycloneDX Cybersecurity ](/terms/cyclonedx) - [Coordinated Vulnerability Disclosure(CVD) Cybersecurity ](/terms/cvd) - [Patchability Cybersecurity ](/terms/patchability) - [Over-the-Air Updates(OTA) Cybersecurity ](/terms/ota-updates) - [Secure Boot Cybersecurity ](/terms/secure-boot) - [Side-Channel Attack Cybersecurity ](/terms/side-channel) - [Hardcoded Credentials Cybersecurity ](/terms/hardcoded-credentials) - [Penetration Testing Cybersecurity ](/terms/pen-test) - [SAST and DAST Cybersecurity ](/terms/sast-dast) - [Refuse to Accept (Cybersecurity)(RTA (cyber)) Cybersecurity ](/terms/rta-cyber) - [IMDRF Principles and Practices for Medical Device Cybersecurity Cybersecurity ](/terms/imdrf-cyber-principles) - [Legacy Device Cybersecurity Cybersecurity ](/terms/legacy-device-cyber) - [HSCC Joint Security Plan(HSCC JSP) Cybersecurity ](/terms/hscc-jsp) - [IEC 80001-1 Cybersecurity ](/terms/iec-80001) - [IEC 81001-5-1 Cybersecurity ](/terms/iec-81001-5-1) - [AAMI TIR57 Cybersecurity ](/terms/aami-tir57) - [AAMI SW96 Cybersecurity ](/terms/aami-sw96) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) Cybersecurity ](/terms/mds2) - [OWASP IoT and Embedded Application Security Cybersecurity ](/terms/owasp-iot) - [NIST Cybersecurity Framework(NIST CSF) Cybersecurity ](/terms/nist-csf) - [NIST SP 800-53 / 800-171(NIST 800-53/171) Cybersecurity ](/terms/nist-800-53) - [ISO/IEC 27001(ISO 27001) Cybersecurity ](/terms/iso-27001) - [HIPAA(HIPAA) Cybersecurity ](/terms/hipaa) - [PHI and ePHI Cybersecurity ](/terms/phi-ephi) - [HITECH Act(HITECH) Cybersecurity ](/terms/hitech-act) - [De-Identification of Health Data Cybersecurity ](/terms/de-identification) - [Zero Trust Architecture(ZTA) Cybersecurity ](/terms/zero-trust) - [Cryptographic Agility Cybersecurity ](/terms/crypto-agility) - [Software Safety Case Cybersecurity ](/terms/software-safety-case) - [Brainjacking Cybersecurity ](/terms/brainjacking) - [Medjacking Cybersecurity ](/terms/medjacking) - [Medhacking Cybersecurity ](/terms/medhacking) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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