--- title: "Compare MedTech Terms - side by side" description: "Compare any two MedTech terms side-by-side. Useful for 510(k) vs PMA, SaMD vs SiMD, QSR vs ISO 13485 and more." lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Compare # Two terms, side by side Pick any two terms to see definitions, context, pitfalls, and sources in parallel. 510(k) vs PMASaMD vs SiMDQSR vs ISO 13485MDR vs IVDRSPDX vs CycloneDX ## Curated comparison tables In-depth, attribute-by-attribute tables for the most common MedTech term pairs. Each row is sourced from the linked term pages. [ Comparison table ### 510(k) vs PMA FDA clearance vs FDA approval: the two main US premarket pathways Open comparison ](/compare/510k-vs-pma)[ Comparison table ### SaMD vs SiMD Software as a Medical Device vs Software in a Medical Device Open comparison ](/compare/samd-vs-simd)[ Comparison table ### ISO 13485 vs 21 CFR 820 (QSR / QMSR) International QMS standard vs the US FDA quality system regulation Open comparison ](/compare/iso-13485-vs-qsr)[ Comparison table ### IEC 62304 vs ISO 14971 Software lifecycle standard vs medical device risk management standard Open comparison ](/compare/iec-62304-vs-iso-14971)[ Comparison table ### EU MDR vs EU IVDR Regulation (EU) 2017/745 vs Regulation (EU) 2017/746 Open comparison ](/compare/mdr-vs-ivdr) Pick a term… 340B Drug Pricing Program (340B) 409A Valuation 5-Day Report 510(k) Premarket Notification (510(k)) 510(k) Summary vs 510(k) Statement 513(g) Request for Information (513(g)) AAMI (AAMI) AAMI SW96 AAMI TIR45 (TIR45) AAMI TIR57 AAMI TIR97 (TIR97) Abbreviated 510(k) Accreditation Scheme for Conformity Assessment (ASCA) Adaptive Trial Design Additional Condition for Nonprescription Use (ACNU) AdvaMed AdvaMed Code of Ethics AdvaMedDx Adversarial Robustness Adverse Event (AE) Advisory Board Aesthetic & Energy-Based Devices AI Act Conformity Assessment (Medical Devices) AI Act Post-Market Monitoring AI Act Prohibited Practices AI Act Serious Incident Reporting AI Act Technical Documentation (Annex IV) AI Act Transparency Obligations AI Imaging Software AI/ML-Enabled Medical Device ALCOA+ Algorithm Change Protocol (ACP) Algorithmic Bias and Fairness Ambulatory Payment Classification (APC) Analytical Performance (IVDR) Analytical Sensitivity Annual Report (PMA) Anti-Dilution Protection Anti-Kickback Statute (AKS) ANVISA (ANVISA) ASC Site-of-Service Shift ASTM F2503 Authorized Representative (EU) (EC REP) Bayesian Trial Design Benefit-Risk Determination Bill of Materials (BOM) Bioburden Biocompatibility Blinding and Masking Bottom-Up Market Sizing Brainjacking Breakthrough Device Designation (BDD) Bridge Round Budget Impact Model (BIM) Bundled Payment Burn Rate Burn Rate and Runway CAPA Effectiveness Check Capitalization Table (Cap Table) Cardiac Rhythm Management (CRM) Cardiovascular Devices Case Report Form (CRF) Category III CPT Code Category III CPT Codes CE Mark Change Control CISA Known Exploited Vulnerabilities Catalog (KEV) Class D Batch Verification (IVDR) Class III Device Cleanroom Classes (ISO 14644) Clinical Decision Support (CDS) Clinical Evaluation Plan (CEP) Clinical Evaluation Report (CER) Clinical Investigation Plan (CIP) Clinical Laboratory Improvement Amendments (CLIA) Clinical Performance (IVDR) CMS IDE Coverage (Category A & B) Code Signing Combination Product Common Specifications (CS) Common Specifications (IVDR) (CS) Common Vulnerabilities and Exposures (CVE) Common Vulnerability Scoring System (CVSS) Common Weakness Enumeration (CWE) Companion Diagnostic (CDx) Companion Diagnostic (IVDR) (CDx) Complaint Handling Composite Endpoint Container Closure Integrity (CCI) Contract Research Organization (CRO) Convertible Note Coordinated Vulnerability Disclosure (CVD) Corporate Venture Capital (CVC) Corrective and Preventive Action (CAPA) Counterfeit Parts and Suspect Components Coverage with Evidence Development (CED) CPT Codes (CPT) Cryptographic Agility Current Procedural Terminology Codes (CPT) Customer Notification Letter CycloneDX Data Governance (AI/ML) Data Safety Monitoring Board (DSMB) Datasheets for Datasets De Novo Classification Request (De Novo) De-Identification of Health Data Decentralized Clinical Trial (DCT) Dental Devices Design Controls Design History File (DHF) Design Transfer Device History Record (DHR) Device Master File (MAF) Device Master Record (DMR) Device Reclassification Petition Diabetes Care Digital Therapeutic (DTx) Digital Therapeutics (DTx) Dilution Distributor vs Direct Sales Document Control Down Round Drag-Along and Tag-Along Rights Drug Delivery Devices Due Diligence Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Early Feasibility Study (EFS) Earn-Out Electronic Data Capture (EDC) Electronic Instructions for Use (eIFU) Electronic Medical Device Reporting (eMDR) Electrophysiology (EP) Emergency Use Authorization (EUA) Employee Option Pool Endoscopy Devices Endotoxin Testing (LAL) Engineering Change Order / Notice (ECO / ECN) ENT Devices Essential Performance eSTAR EU AI Act EU In Vitro Diagnostic Regulation (IVDR) EU Medical Device Regulation (MDR) EU Reference Laboratory (EURL) (EURL) EUDAMED Exit Multiple Explainability and Interpretability Failure Mode and Effects Analysis (FMEA) Fault Tree Analysis (FTA) FDA Form 483 FDA Recall Classifications I, II, III FDA Recognized Consensus Standards Feasibility Study Federated Learning FedRAMP (FedRAMP) Field Action vs Recall Field Clinical Engineer (FCE) Field Safety Corrective Action (FSCA) First-in-Human Study (FIH) Fogarty Innovation Foundation Model (Healthcare) Freedom to Operate (FTO) Fundamental Rights Impact Assessment (FRIA) General Controls General Safety and Performance Requirements (GSPRs) General Safety and Performance Requirements (IVDR) (GSPR) General-Purpose AI Model (GPAI) Generative AI in Medical Devices Genetic Testing Requirements (IVDR Article 4) Global Unique Device Identification Database (GUDID) Good Clinical Practice (GCP) Good Machine Learning Practice (GMLP) Group Purchasing Organization (GPO) Hardcoded Credentials Hardware Root of Trust (HRoT) Hazard, Hazardous Situation, and Harm HCPCS Codes (HCPCS) Health Canada Medical Device Licence (MDL) Health Economics and Outcomes Research (HEOR) Health Hazard Evaluation (HHE) Health Industry Cybersecurity Practices (HICP) Health Information Sharing and Analysis Center (H-ISAC) Health Technology Assessment (HTA) Healthcare and Public Health Cybersecurity Performance Goals (HPH-CPG) Hearing Devices High-Risk AI System (EU AI Act) HIPAA (HIPAA) HITECH Act (HITECH) HITRUST CSF (HITRUST) HSCC Joint Security Plan (HSCC JSP) Human Factors Engineering (HFE) Humanitarian Device Exemption (HDE) ICD-10-CM / ICD-10-PCS ICH E6 Good Clinical Practice (GCP) ICH E6(R3) Good Clinical Practice (E6(R3)) ICS Medical Advisory (ICSMA) IDE Annual Progress Report IDE Supplement IEC 60601-1 IEC 60601-1-2 IEC 60825 IEC 62304 IEC 62366-1 IEC 80001-1 IEC 81001-5-1 IEC 82304-1 IMDRF IMDRF Principles and Practices for Medical Device Cybersecurity Importer and Distributor Obligations (EU) In Vitro Diagnostics (IVD) In Vitro Diagnostics (Segment) (IVD) In-House IVDs (Article 5(5)) Incremental Cost-Effectiveness Ratio (ICER) Indications for Use (IFU (statement)) Industry Trade Organizations Informed Consent Initial Public Offering (IPO) Inpatient Prospective Payment System (IPPS) Institutional Review Board (IRB) Instructions for Use (IFU) Integrated Delivery Network (IDN) Intended Use Intent-to-Treat vs Per-Protocol (ITT / PP) Internal Audit Interoperability Investigational Device Exemption (IDE) Investigator Brochure (IB) Investigator-Initiated Trial (IIT) IQ / OQ / PQ ISO 10993-1 ISO 11135 ISO 11137 ISO 11607-1/-2 ISO 13485 ISO 14155 ISO 14971 ISO 15223-1 Symbols ISO 17665 ISO 20417 ISO 20916 ISO 22301 ISO 31000 ISO/IEC 23894 ISO/IEC 27001 (ISO 27001) ISO/TR 24971 IVDR Conformity Assessment Routes IVDR Legacy Device IVDR Performance Evaluation IVDR Risk Classes A–D IVDR Transitional Provisions Joint Clinical Assessment (JCA) Key Opinion Leader (KOL) Label Claims Labeling Laboratory-Developed Test (LDT) Launch Readiness LCD and NCD Legacy Device Cybersecurity Letter to File (LTF) Limit of Detection / Limit of Quantitation (LoD / LoQ) Limited Partner / General Partner (LP / GP) LINDDUN Liquidation Preference Liquidity Event Locked vs. Adaptive Algorithm Lost to Follow-up Lot Traceability Managed Service / Reagent Rental Management Representative Management Review Manufacturer Disclosure Statement for Medical Device Security (MDS2) Manufacturer Incident Report (MIR) Master Protocol (Basket / Umbrella / Platform) MDR Article 117 Medhacking Medical Device Coordination Group Guidance (MDCG) Medical Device Data System (MDDS) Medical Device Innovation Consortium (MDIC) Medical Device Recall Medical Device Reporting (FDA) (MDR) Medical Device Single Audit Program (MDSAP) Medical Device User Fee Amendments (MDUFA) Medical Device Vigilance Medical Imaging Medicare Administrative Contractor (MAC) Medicare Physician Fee Schedule (MPFS) Medjacking MedTech Accelerators and Incubators MedTech Innovator Mergers and Acquisitions (M&A) Metrological Traceability (IVDR) MHRA / UKCA Marking (MHRA / UKCA) Milestone Payment Milestone-Based Tranche Minimal Clinically Important Difference (MCID) Ministry of Food and Drug Safety (Korea) (MFDS) MITRE ATT&CK (ATT&CK) MITRE D3FEND (D3FEND) MLOps for Medical Devices (MLOps) Model Card Model Drift Monitoring Modular PMA Molecular Diagnostics MRP and ERP Systems (MRP / ERP) MS-DRG (MS-DRG) National and Local Coverage Determinations (NCD / LCD) National Medical Products Administration (NMPA) Neuromodulation New Technology Add-On Payment (NTAP) NIST Cybersecurity Framework (NIST CSF) NIST IR 8473, Cybersecurity Framework Profile for HPH (NIST IR 8473) NIST SP 800-53 / 800-171 (NIST 800-53/171) NMPA Innovative Medical Device Pathway Non-Dilutive Funding Non-Inferiority Trial Nonconformance (NCR) (NCR) Notified Body (NB) Notified Body Scrutiny (IVDR Class D) Off-Label Use ONC HTI-1 / HTI-2 Ophthalmology Devices Orthopedic Devices Outpatient Prospective Payment System (OPPS) Over-the-Air Updates (OTA) OWASP IoT and Embedded Application Security Patchability Patient Monitoring Penetration Testing Performance Study (IVDR) Performance Study Application (IVDR) Periodic Safety Update Report (PSUR) Person Responsible for Regulatory Compliance (PRRC) Pharmaceuticals and Medical Devices Agency (PMDA) PHI and ePHI Physician Payments Sunshine Act Physician Training and Proctoring Pivotal Trial PMA Supplement Types Point-of-Care Diagnostics (POC) Post-Market Clinical Follow-up (PMCF) Post-Market Performance Follow-up (PMPF) Post-Market Performance Follow-Up (IVDR) (PMPF) Post-Market Surveillance (PMS) Post-Market Surveillance Plan Post-Market Surveillance Plan (IVDR) Post-Money Valuation Post-Production Information (Risk) Pragmatic Trial Pre-Approval Inspection (PAI) Pre-Money Valuation Pre-Submission Meeting (Q-Sub) Predetermined Change Control Plan (PCCP) Predetermined Maintenance vs PCCP Predicate Device Preferred Stock Premarket Approval (PMA) Premarket Cybersecurity Submission Primary and Secondary Endpoints Prior Authorization Pro-Rata Rights Process Capability (Cp/Cpk) and SPC Process Capability and Cpk Process FMEA vs Design FMEA (PFMEA / DFMEA) Process Validation Production and Process Controls Propensity Score Methods Proprietary Laboratory Analyses Codes (PLA) Protecting Access to Medicare Act (PAMA) Protocol Deviation Provider and Deployer (EU AI Act) PSUR (IVDR Specific) Q-Submission (Pre-Submission) (Q-Sub / Pre-Sub) Quality Management System Regulation (QMSR) Quality Manual Quality System Regulation (QSR / 21 CFR 820) Quality-Adjusted Life Year (QALY) Razor / Razor-Blade Model Real-Time PMA Supplement Review Real-World Data (RWD) Real-World Evidence (RWE) Recovery Audit Contractor (RAC) Refuse to Accept (RTA) Refuse to Accept (Cybersecurity) (RTA (cyber)) Regulatory Affairs Professionals Society (RAPS) Remote Patient Monitoring (RPM) Removal vs Correction (21 CFR 806) Renal Care Devices Request for Designation (RFD) Respiratory Devices Risk Acceptability Matrix Risk Management File (RMF) Risk-Based Monitoring (RBM) Royalty Financing Runway RWE for Reimbursement Safer Technologies Program (STeP) Sample Size and Statistical Power SAST and DAST Saudi Food and Drug Authority (SFDA) SBIR / STTR Grants (SBIR/STTR) Scientific Validity (IVDR) Scrap Rate and Yield Section 522 Postmarket Surveillance (Section 522) Section 524B of the FD&C Act (524B) Secure Boot Secure Product Development Framework (SPDF) Secure Software Development Framework (SSDF) Secure-by-Design (Devices) Self-Test and Near-Patient Testing (IVDR) Series A / B / C Financing Rounds Serious Adverse Event (SAE) Servicing (21 CFR 820.200) Sham Control Shelf Life Side-Channel Attack Simple Agreement for Future Equity (SAFE) Single-Use Device (SUD) Site-Neutral Payment Sleep & Respiratory Devices SOC 2 Software as a Medical Device (SaMD) Software Bill of Materials (SBOM) Software in a Medical Device (SiMD) Software Maintenance Plan Software of Unknown Provenance (SOUP) Software Safety Case Software Safety Classification Source Data Verification (SDV) SPDX (SPDX) Special 510(k) (Special 510(k)) Special Controls Special Purpose Acquisition Company (SPAC) Specialty MedTech Venture Capital Spine Stability Testing Stark Law Sterilization Strategic Acquisition Strategic Investor STRIDE Threat Model (STRIDE) Structural Heart Substantial Equivalence (SE) Summary of Safety and Clinical Performance (SSCP) Summary of Safety and Performance (IVDR) (SSP) Summative vs. Formative Evaluation Supplier Controls Supply-chain Levels for Software Artifacts (SLSA) Surgical Robotics Surrogate Endpoint Swissmedic Synthetic Data Systemic Risk (GPAI) TAM / SAM / SOM Technology Transfer (Manufacturing) Term Sheet Texas Medical Center Innovation (TMC Innovation) Therapeutic Goods Administration (TGA) Third-Party Review of 510(k) (3P 510(k)) Threat Modeling Total Product Lifecycle (TPLC) Training Records Tranched Financing Transitional Coverage for Emerging Technologies (TCET) Transitional Pass-Through Payment (TPT) Trend Reporting (MDR/MIR) Trial Master File (TMF) UDI-DI vs. UDI-PI UK Responsible Person (UKRP) Unanticipated Adverse Device Effect (UADE) Unique Device Identification (UDI) Urology Devices Use Error Use Specification Use-Related Risk Analysis (URRA) Validation Master Plan (VMP) Valuation Cap Value Analysis Committee (VAC) Value-Based Care (VBC) Venture Debt Verification & Validation (V&V) Vesting Schedule Vulnerability Exploitability eXchange (VEX) Warning Letter Wearable Medical Devices Wearables and Remote Patient Monitoring (RPM) WHO Prequalification (Diagnostics) (WHO PQ Dx) Women's Health Devices Wound Care Zero Trust Architecture (ZTA) Select term A to compare. Pick a term… 340B Drug Pricing Program (340B) 409A Valuation 5-Day Report 510(k) Premarket Notification (510(k)) 510(k) Summary vs 510(k) Statement 513(g) Request for Information (513(g)) AAMI (AAMI) AAMI SW96 AAMI TIR45 (TIR45) AAMI TIR57 AAMI TIR97 (TIR97) Abbreviated 510(k) Accreditation Scheme for Conformity Assessment (ASCA) Adaptive Trial Design Additional Condition for Nonprescription Use (ACNU) AdvaMed AdvaMed Code of Ethics AdvaMedDx Adversarial Robustness Adverse Event (AE) Advisory Board Aesthetic & Energy-Based Devices AI Act Conformity Assessment (Medical Devices) AI Act Post-Market Monitoring AI Act Prohibited Practices AI Act Serious Incident Reporting AI Act Technical Documentation (Annex IV) AI Act Transparency Obligations AI Imaging Software AI/ML-Enabled Medical Device ALCOA+ Algorithm Change Protocol (ACP) Algorithmic Bias and Fairness Ambulatory Payment Classification (APC) Analytical Performance (IVDR) Analytical Sensitivity Annual Report (PMA) Anti-Dilution Protection Anti-Kickback Statute (AKS) ANVISA (ANVISA) ASC Site-of-Service Shift ASTM F2503 Authorized Representative (EU) (EC REP) Bayesian Trial Design Benefit-Risk Determination Bill of Materials (BOM) Bioburden Biocompatibility Blinding and Masking Bottom-Up Market Sizing Brainjacking Breakthrough Device Designation (BDD) Bridge Round Budget Impact Model (BIM) Bundled Payment Burn Rate Burn Rate and Runway CAPA Effectiveness Check Capitalization Table (Cap Table) Cardiac Rhythm Management (CRM) Cardiovascular Devices Case Report Form (CRF) Category III CPT Code Category III CPT Codes CE Mark Change Control CISA Known Exploited Vulnerabilities Catalog (KEV) Class D Batch Verification (IVDR) Class III Device Cleanroom Classes (ISO 14644) Clinical Decision Support (CDS) Clinical Evaluation Plan (CEP) Clinical Evaluation Report (CER) Clinical Investigation Plan (CIP) Clinical Laboratory Improvement Amendments (CLIA) Clinical Performance (IVDR) CMS IDE Coverage (Category A & B) Code Signing Combination Product Common Specifications (CS) Common Specifications (IVDR) (CS) Common Vulnerabilities and Exposures (CVE) Common Vulnerability Scoring System (CVSS) Common Weakness Enumeration (CWE) Companion Diagnostic (CDx) Companion Diagnostic (IVDR) (CDx) Complaint Handling Composite Endpoint Container Closure Integrity (CCI) Contract Research Organization (CRO) Convertible Note Coordinated Vulnerability Disclosure (CVD) Corporate Venture Capital (CVC) Corrective and Preventive Action (CAPA) Counterfeit Parts and Suspect Components Coverage with Evidence Development (CED) CPT Codes (CPT) Cryptographic Agility Current Procedural Terminology Codes (CPT) Customer Notification Letter CycloneDX Data Governance (AI/ML) Data Safety Monitoring Board (DSMB) Datasheets for Datasets De Novo Classification Request (De Novo) De-Identification of Health Data Decentralized Clinical Trial (DCT) Dental Devices Design Controls Design History File (DHF) Design Transfer Device History Record (DHR) Device Master File (MAF) Device Master Record (DMR) Device Reclassification Petition Diabetes Care Digital Therapeutic (DTx) Digital Therapeutics (DTx) Dilution Distributor vs Direct Sales Document Control Down Round Drag-Along and Tag-Along Rights Drug Delivery Devices Due Diligence Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Early Feasibility Study (EFS) Earn-Out Electronic Data Capture (EDC) Electronic Instructions for Use (eIFU) Electronic Medical Device Reporting (eMDR) Electrophysiology (EP) Emergency Use Authorization (EUA) Employee Option Pool Endoscopy Devices Endotoxin Testing (LAL) Engineering Change Order / Notice (ECO / ECN) ENT Devices Essential Performance eSTAR EU AI Act EU In Vitro Diagnostic Regulation (IVDR) EU Medical Device Regulation (MDR) EU Reference Laboratory (EURL) (EURL) EUDAMED Exit Multiple Explainability and Interpretability Failure Mode and Effects Analysis (FMEA) Fault Tree Analysis (FTA) FDA Form 483 FDA Recall Classifications I, II, III FDA Recognized Consensus Standards Feasibility Study Federated Learning FedRAMP (FedRAMP) Field Action vs Recall Field Clinical Engineer (FCE) Field Safety Corrective Action (FSCA) First-in-Human Study (FIH) Fogarty Innovation Foundation Model (Healthcare) Freedom to Operate (FTO) Fundamental Rights Impact Assessment (FRIA) General Controls General Safety and Performance Requirements (GSPRs) General Safety and Performance Requirements (IVDR) (GSPR) General-Purpose AI Model (GPAI) Generative AI in Medical Devices Genetic Testing Requirements (IVDR Article 4) Global Unique Device Identification Database (GUDID) Good Clinical Practice (GCP) Good Machine Learning Practice (GMLP) Group Purchasing Organization (GPO) Hardcoded Credentials Hardware Root of Trust (HRoT) Hazard, Hazardous Situation, and Harm HCPCS Codes (HCPCS) Health Canada Medical Device Licence (MDL) Health Economics and Outcomes Research (HEOR) Health Hazard Evaluation (HHE) Health Industry Cybersecurity Practices (HICP) Health Information Sharing and Analysis Center (H-ISAC) Health Technology Assessment (HTA) Healthcare and Public Health Cybersecurity Performance Goals (HPH-CPG) Hearing Devices High-Risk AI System (EU AI Act) HIPAA (HIPAA) HITECH Act (HITECH) HITRUST CSF (HITRUST) HSCC Joint Security Plan (HSCC JSP) Human Factors Engineering (HFE) Humanitarian Device Exemption (HDE) ICD-10-CM / ICD-10-PCS ICH E6 Good Clinical Practice (GCP) ICH E6(R3) Good Clinical Practice (E6(R3)) ICS Medical Advisory (ICSMA) IDE Annual Progress Report IDE Supplement IEC 60601-1 IEC 60601-1-2 IEC 60825 IEC 62304 IEC 62366-1 IEC 80001-1 IEC 81001-5-1 IEC 82304-1 IMDRF IMDRF Principles and Practices for Medical Device Cybersecurity Importer and Distributor Obligations (EU) In Vitro Diagnostics (IVD) In Vitro Diagnostics (Segment) (IVD) In-House IVDs (Article 5(5)) Incremental Cost-Effectiveness Ratio (ICER) Indications for Use (IFU (statement)) Industry Trade Organizations Informed Consent Initial Public Offering (IPO) Inpatient Prospective Payment System (IPPS) Institutional Review Board (IRB) Instructions for Use (IFU) Integrated Delivery Network (IDN) Intended Use Intent-to-Treat vs Per-Protocol (ITT / PP) Internal Audit Interoperability Investigational Device Exemption (IDE) Investigator Brochure (IB) Investigator-Initiated Trial (IIT) IQ / OQ / PQ ISO 10993-1 ISO 11135 ISO 11137 ISO 11607-1/-2 ISO 13485 ISO 14155 ISO 14971 ISO 15223-1 Symbols ISO 17665 ISO 20417 ISO 20916 ISO 22301 ISO 31000 ISO/IEC 23894 ISO/IEC 27001 (ISO 27001) ISO/TR 24971 IVDR Conformity Assessment Routes IVDR Legacy Device IVDR Performance Evaluation IVDR Risk Classes A–D IVDR Transitional Provisions Joint Clinical Assessment (JCA) Key Opinion Leader (KOL) Label Claims Labeling Laboratory-Developed Test (LDT) Launch Readiness LCD and NCD Legacy Device Cybersecurity Letter to File (LTF) Limit of Detection / Limit of Quantitation (LoD / LoQ) Limited Partner / General Partner (LP / GP) LINDDUN Liquidation Preference Liquidity Event Locked vs. Adaptive Algorithm Lost to Follow-up Lot Traceability Managed Service / Reagent Rental Management Representative Management Review Manufacturer Disclosure Statement for Medical Device Security (MDS2) Manufacturer Incident Report (MIR) Master Protocol (Basket / Umbrella / Platform) MDR Article 117 Medhacking Medical Device Coordination Group Guidance (MDCG) Medical Device Data System (MDDS) Medical Device Innovation Consortium (MDIC) Medical Device Recall Medical Device Reporting (FDA) (MDR) Medical Device Single Audit Program (MDSAP) Medical Device User Fee Amendments (MDUFA) Medical Device Vigilance Medical Imaging Medicare Administrative Contractor (MAC) Medicare Physician Fee Schedule (MPFS) Medjacking MedTech Accelerators and Incubators MedTech Innovator Mergers and Acquisitions (M&A) Metrological Traceability (IVDR) MHRA / UKCA Marking (MHRA / UKCA) Milestone Payment Milestone-Based Tranche Minimal Clinically Important Difference (MCID) Ministry of Food and Drug Safety (Korea) (MFDS) MITRE ATT&CK (ATT&CK) MITRE D3FEND (D3FEND) MLOps for Medical Devices (MLOps) Model Card Model Drift Monitoring Modular PMA Molecular Diagnostics MRP and ERP Systems (MRP / ERP) MS-DRG (MS-DRG) National and Local Coverage Determinations (NCD / LCD) National Medical Products Administration (NMPA) Neuromodulation New Technology Add-On Payment (NTAP) NIST Cybersecurity Framework (NIST CSF) NIST IR 8473, Cybersecurity Framework Profile for HPH (NIST IR 8473) NIST SP 800-53 / 800-171 (NIST 800-53/171) NMPA Innovative Medical Device Pathway Non-Dilutive Funding Non-Inferiority Trial Nonconformance (NCR) (NCR) Notified Body (NB) Notified Body Scrutiny (IVDR Class D) Off-Label Use ONC HTI-1 / HTI-2 Ophthalmology Devices Orthopedic Devices Outpatient Prospective Payment System (OPPS) Over-the-Air Updates (OTA) OWASP IoT and Embedded Application Security Patchability Patient Monitoring Penetration Testing Performance Study (IVDR) Performance Study Application (IVDR) Periodic Safety Update Report (PSUR) Person Responsible for Regulatory Compliance (PRRC) Pharmaceuticals and Medical Devices Agency (PMDA) PHI and ePHI Physician Payments Sunshine Act Physician Training and Proctoring Pivotal Trial PMA Supplement Types Point-of-Care Diagnostics (POC) Post-Market Clinical Follow-up (PMCF) Post-Market Performance Follow-up (PMPF) Post-Market Performance Follow-Up (IVDR) (PMPF) Post-Market Surveillance (PMS) Post-Market Surveillance Plan Post-Market Surveillance Plan (IVDR) Post-Money Valuation Post-Production Information (Risk) Pragmatic Trial Pre-Approval Inspection (PAI) Pre-Money Valuation Pre-Submission Meeting (Q-Sub) Predetermined Change Control Plan (PCCP) Predetermined Maintenance vs PCCP Predicate Device Preferred Stock Premarket Approval (PMA) Premarket Cybersecurity Submission Primary and Secondary Endpoints Prior Authorization Pro-Rata Rights Process Capability (Cp/Cpk) and SPC Process Capability and Cpk Process FMEA vs Design FMEA (PFMEA / DFMEA) Process Validation Production and Process Controls Propensity Score Methods Proprietary Laboratory Analyses Codes (PLA) Protecting Access to Medicare Act (PAMA) Protocol Deviation Provider and Deployer (EU AI Act) PSUR (IVDR Specific) Q-Submission (Pre-Submission) (Q-Sub / Pre-Sub) Quality Management System Regulation (QMSR) Quality Manual Quality System Regulation (QSR / 21 CFR 820) Quality-Adjusted Life Year (QALY) Razor / Razor-Blade Model Real-Time PMA Supplement Review Real-World Data (RWD) Real-World Evidence (RWE) Recovery Audit Contractor (RAC) Refuse to Accept (RTA) Refuse to Accept (Cybersecurity) (RTA (cyber)) Regulatory Affairs Professionals Society (RAPS) Remote Patient Monitoring (RPM) Removal vs Correction (21 CFR 806) Renal Care Devices Request for Designation (RFD) Respiratory Devices Risk Acceptability Matrix Risk Management File (RMF) Risk-Based Monitoring (RBM) Royalty Financing Runway RWE for Reimbursement Safer Technologies Program (STeP) Sample Size and Statistical Power SAST and DAST Saudi Food and Drug Authority (SFDA) SBIR / STTR Grants (SBIR/STTR) Scientific Validity (IVDR) Scrap Rate and Yield Section 522 Postmarket Surveillance (Section 522) Section 524B of the FD&C Act (524B) Secure Boot Secure Product Development Framework (SPDF) Secure Software Development Framework (SSDF) Secure-by-Design (Devices) Self-Test and Near-Patient Testing (IVDR) Series A / B / C Financing Rounds Serious Adverse Event (SAE) Servicing (21 CFR 820.200) Sham Control Shelf Life Side-Channel Attack Simple Agreement for Future Equity (SAFE) Single-Use Device (SUD) Site-Neutral Payment Sleep & Respiratory Devices SOC 2 Software as a Medical Device (SaMD) Software Bill of Materials (SBOM) Software in a Medical Device (SiMD) Software Maintenance Plan Software of Unknown Provenance (SOUP) Software Safety Case Software Safety Classification Source Data Verification (SDV) SPDX (SPDX) Special 510(k) (Special 510(k)) Special Controls Special Purpose Acquisition Company (SPAC) Specialty MedTech Venture Capital Spine Stability Testing Stark Law Sterilization Strategic Acquisition Strategic Investor STRIDE Threat Model (STRIDE) Structural Heart Substantial Equivalence (SE) Summary of Safety and Clinical Performance (SSCP) Summary of Safety and Performance (IVDR) (SSP) Summative vs. Formative Evaluation Supplier Controls Supply-chain Levels for Software Artifacts (SLSA) Surgical Robotics Surrogate Endpoint Swissmedic Synthetic Data Systemic Risk (GPAI) TAM / SAM / SOM Technology Transfer (Manufacturing) Term Sheet Texas Medical Center Innovation (TMC Innovation) Therapeutic Goods Administration (TGA) Third-Party Review of 510(k) (3P 510(k)) Threat Modeling Total Product Lifecycle (TPLC) Training Records Tranched Financing Transitional Coverage for Emerging Technologies (TCET) Transitional Pass-Through Payment (TPT) Trend Reporting (MDR/MIR) Trial Master File (TMF) UDI-DI vs. UDI-PI UK Responsible Person (UKRP) Unanticipated Adverse Device Effect (UADE) Unique Device Identification (UDI) Urology Devices Use Error Use Specification Use-Related Risk Analysis (URRA) Validation Master Plan (VMP) Valuation Cap Value Analysis Committee (VAC) Value-Based Care (VBC) Venture Debt Verification & Validation (V&V) Vesting Schedule Vulnerability Exploitability eXchange (VEX) Warning Letter Wearable Medical Devices Wearables and Remote Patient Monitoring (RPM) WHO Prequalification (Diagnostics) (WHO PQ Dx) Women's Health Devices Wound Care Zero Trust Architecture (ZTA) Select term B to compare. ## Why compare MedTech terms side by side? MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes. Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives. ### Common comparison patterns - **Regulatory pathway choice** - [510(k) vs PMA](/compare?a=510k&b=pma), [510(k) vs De Novo](/compare?a=510k&b=de-novo), [Abbreviated vs Special 510(k)](/compare?a=abbreviated-510k&b=special-510k). - **Quality systems** - [QSR vs ISO 13485](/compare?a=qsr&b=iso-13485), [QMSR vs QSR](/compare?a=qmsr&b=qsr). - **Software classification** - [SaMD vs SiMD](/compare?a=samd&b=simd), [Locked vs adaptive AI](/compare?a=locked-vs-adaptive&b=ai-ml-pccp). - **EU frameworks** - [MDR vs IVDR](/compare?a=mdr&b=ivdr), [CE Mark vs UKCA](/compare?a=ce-mark&b=mhra-ukca). - **Cybersecurity artifacts** - [SPDX vs CycloneDX SBOM](/compare?a=spdx&b=cyclonedx), [CVE vs CVSS](/compare?a=cve&b=cvss). - **Post-market actions** - [Recall vs field action](/compare?a=recall&b=field-action-vs-recall), [Removal vs correction](/compare?a=removal-vs-correction&b=recall). ### How to use this tool Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click _Open full page_ on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the [Categories](/categories) view or the [A-Z index](/a-z). MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice. MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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