MedTech Terms
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    Study the glossary step by step

    Pick a category, work through Foundations first, then Intermediate and Advanced. Foundations are the terms other pages refer to most. Use "Save my progress" on a term page and it is ticked here.

    1. Foundations
    Core concepts other terms build on. Start here.
    2. Intermediate
    Applied concepts that assume the foundations.
    3. Advanced
    Specialist and niche topics for deeper study.

    Regulatory

    0 / 101 studied

    FDA, EU MDR/IVDR, and global pathways for getting devices to market.

    Step 1: Foundations (34)

    1. EU In Vitro Diagnostic Regulation (IVDR)
    2. 510(k) Premarket Notification (510(k))
    3. EU Medical Device Regulation (MDR)
    4. Premarket Approval (PMA)
    5. Notified Body (NB)
    6. De Novo Classification Request (De Novo)
    7. EUDAMED
    8. High-Risk AI System (EU AI Act)
    9. Unique Device Identification (UDI)
    10. IVDR Risk Classes A–D
    11. Labeling
    12. IMDRF
    13. IVDR Performance Evaluation
    14. Combination Product
    15. Substantial Equivalence (SE)
    16. Authorized Representative (EU) (EC REP)
    17. CE Mark
    18. Clinical Performance (IVDR)
    19. General Safety and Performance Requirements (GSPRs)
    20. Instructions for Use (IFU)
    21. Predicate Device
    22. Abbreviated 510(k)
    23. Benefit-Risk Determination
    24. Breakthrough Device Designation (BDD)
    25. FDA Recognized Consensus Standards
    26. Refuse to Accept (RTA)
    27. Analytical Performance (IVDR)
    28. Class III Device
    29. Common Specifications (CS)
    30. Common Specifications (IVDR) (CS)
    31. General Controls
    32. Intended Use
    33. Letter to File (LTF)
    34. Medical Device Coordination Group Guidance (MDCG)
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    Step 2: Intermediate (34)

    1. Metrological Traceability (IVDR)
    2. MHRA / UKCA Marking (MHRA / UKCA)
    3. Modular PMA
    4. PMA Supplement Types
    5. Q-Submission (Pre-Submission) (Q-Sub / Pre-Sub)
    6. Real-Time PMA Supplement Review
    7. Request for Designation (RFD)
    8. Scientific Validity (IVDR)
    9. Special 510(k) (Special 510(k))
    10. Special Controls
    11. Accreditation Scheme for Conformity Assessment (ASCA)
    12. AI Act Conformity Assessment (Medical Devices)
    13. AI Act Technical Documentation (Annex IV)
    14. Clinical Evaluation Consultation Procedure (CECP)
    15. Companion Diagnostic (IVDR) (CDx)
    16. eSTAR
    17. EU Reference Laboratory (EURL) (EURL)
    18. Fundamental Rights Impact Assessment (FRIA)
    19. General-Purpose AI Model (GPAI)
    20. Indications for Use (IFU (statement))
    21. IVDR Legacy Device
    22. MDR Article 117
    23. National Medical Products Administration (NMPA)
    24. Notified Body Scrutiny (IVDR Class D)
    25. Person Responsible for Regulatory Compliance (PRRC)
    26. Pharmaceuticals and Medical Devices Agency (PMDA)
    27. Post-Market Performance Follow-Up (IVDR) (PMPF)
    28. Post-Market Surveillance Plan (IVDR)
    29. Provider and Deployer (EU AI Act)
    30. Self-Test and Near-Patient Testing (IVDR)
    31. Summary of Safety and Clinical Performance (SSCP)
    32. Technical Documentation
    33. Therapeutic Goods Administration (TGA)
    34. Third-Party Review of 510(k) (3P 510(k))
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    Step 3: Advanced (33)

    1. UK Responsible Person (UKRP)
    2. 510(k) Summary vs 510(k) Statement
    3. 513(g) Request for Information (513(g))
    4. Additional Condition for Nonprescription Use (ACNU)
    5. AI Act Post-Market Monitoring
    6. AI Act Prohibited Practices
    7. AI Act Serious Incident Reporting
    8. AI Act Transparency Obligations
    9. ANVISA (ANVISA)
    10. Class D Batch Verification (IVDR)
    11. Device Master File (MAF)
    12. Device Reclassification Petition
    13. Electronic Instructions for Use (eIFU)
    14. Emergency Use Authorization (EUA)
    15. General Safety and Performance Requirements (IVDR) (GSPR)
    16. Genetic Testing Requirements (IVDR Article 4)
    17. Health Canada Medical Device Licence (MDL)
    18. Humanitarian Device Exemption (HDE)
    19. Importer and Distributor Obligations (EU)
    20. In-House IVDs (Article 5(5))
    21. ISO 20916
    22. IVDR Conformity Assessment Routes
    23. IVDR Transitional Provisions
    24. Medical Device User Fee Amendments (MDUFA)
    25. Ministry of Food and Drug Safety (Korea) (MFDS)
    26. NMPA Innovative Medical Device Pathway
    27. Performance Study Application (IVDR)
    28. Safer Technologies Program (STeP)
    29. Saudi Food and Drug Authority (SFDA)
    30. Summary of Safety and Performance (IVDR) (SSP)
    31. Swissmedic
    32. Systemic Risk (GPAI)
    33. WHO Prequalification (Diagnostics) (WHO PQ Dx)
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    Cybersecurity

    0 / 61 studied

    Threat modeling, SBOMs, and secure-by-design for connected devices.

    Step 1: Foundations (21)

    1. Premarket Cybersecurity Submission
    2. Section 524B of the FD&C Act (524B)
    3. Threat Modeling
    4. Secure Product Development Framework (SPDF)
    5. IEC 81001-5-1
    6. Software Bill of Materials (SBOM)
    7. HIPAA (HIPAA)
    8. NIST Cybersecurity Framework (NIST CSF)
    9. Postmarket Cybersecurity Management
    10. Vulnerability Exploitability eXchange (VEX)
    11. Coordinated Vulnerability Disclosure (CVD)
    12. Secure Boot
    13. AAMI TIR57
    14. HSCC Joint Security Plan (HSCC JSP)
    15. Common Vulnerabilities and Exposures (CVE)
    16. ISO/IEC 27001 (ISO 27001)
    17. Patchability
    18. Common Vulnerability Scoring System (CVSS)
    19. CycloneDX
    20. IEC 80001-1
    21. Penetration Testing
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    Step 2: Intermediate (20)

    1. Hardcoded Credentials
    2. Health Industry Cybersecurity Practices (HICP)
    3. Health Information Sharing and Analysis Center (H-ISAC)
    4. HITECH Act (HITECH)
    5. IMDRF Principles and Practices for Medical Device Cybersecurity
    6. NIST SP 800-53 / 800-171 (NIST 800-53/171)
    7. Over-the-Air Updates (OTA)
    8. PHI and ePHI
    9. SPDX (SPDX)
    10. De-Identification of Health Data
    11. Legacy Device Cybersecurity
    12. SAST and DAST
    13. STRIDE Threat Model (STRIDE)
    14. AAMI SW96
    15. Brainjacking
    16. CISA Known Exploited Vulnerabilities Catalog (KEV)
    17. FedRAMP (FedRAMP)
    18. Healthcare and Public Health Cybersecurity Performance Goals (HPH-CPG)
    19. HITRUST CSF (HITRUST)
    20. ICS Medical Advisory (ICSMA)
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    Step 3: Advanced (20)

    1. Manufacturer Disclosure Statement for Medical Device Security (MDS2)
    2. Medjacking
    3. SOC 2
    4. Code Signing
    5. Cryptographic Agility
    6. Hardware Root of Trust (HRoT)
    7. Medhacking
    8. MITRE ATT&CK (ATT&CK)
    9. MITRE D3FEND (D3FEND)
    10. OWASP IoT and Embedded Application Security
    11. Refuse to Accept (Cybersecurity) (RTA (cyber))
    12. Secure Software Development Framework (SSDF)
    13. Supply-chain Levels for Software Artifacts (SLSA)
    14. AAMI TIR97 (TIR97)
    15. Common Weakness Enumeration (CWE)
    16. LINDDUN
    17. NIST CSWP 35, Cybersecurity Threat Modeling the Genomic Data Sequencing Workflow (NIST CSWP 35)
    18. Side-Channel Attack
    19. Software Safety Case
    20. Zero Trust Architecture (ZTA)
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    Clinical & Trials

    0 / 52 studied

    Clinical evidence, investigations, and human-factors studies.

    Step 1: Foundations (18)

    1. Investigational Device Exemption (IDE)
    2. ICH E6 Good Clinical Practice (GCP)
    3. Pivotal Trial
    4. Real-World Evidence (RWE)
    5. Human Factors Engineering (HFE)
    6. Adaptive Trial Design
    7. Informed Consent
    8. Institutional Review Board (IRB)
    9. ALCOA+
    10. Composite Endpoint
    11. Bayesian Trial Design
    12. Clinical Evaluation Report (CER)
    13. Decentralized Clinical Trial (DCT)
    14. Early Feasibility Study (EFS)
    15. Electronic Data Capture (EDC)
    16. IDE Supplement
    17. Protocol Deviation
    18. Source Data Verification (SDV)
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    Step 2: Intermediate (17)

    1. Trial Master File (TMF)
    2. Adverse Event (AE)
    3. Case Report Form (CRF)
    4. Clinical Investigation Plan (CIP)
    5. Data Safety Monitoring Board (DSMB)
    6. Feasibility Study
    7. Investigator Brochure (IB)
    8. Minimal Clinically Important Difference (MCID)
    9. Primary and Secondary Endpoints
    10. Risk-Based Monitoring (RBM)
    11. Surrogate Endpoint
    12. Unanticipated Adverse Device Effect (UADE)
    13. Use Error
    14. Analytical Sensitivity
    15. Blinding and Masking
    16. Clinical Evaluation Plan (CEP)
    17. Core Laboratory
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    Step 3: Advanced (17)

    1. First-in-Human Study (FIH)
    2. IDE Annual Progress Report
    3. Intent-to-Treat vs Per-Protocol (ITT / PP)
    4. Limit of Detection / Limit of Quantitation (LoD / LoQ)
    5. Lost to Follow-up
    6. Non-Inferiority Trial
    7. Performance Study (IVDR)
    8. Pharmacogenomics (PGx)
    9. Real-World Data (RWD)
    10. Sample Size and Statistical Power
    11. Serious Adverse Event (SAE)
    12. Sham Control
    13. Electronic Patient-Reported Outcome (ePRO)
    14. Investigator-Initiated Trial (IIT)
    15. Master Protocol (Basket / Umbrella / Platform)
    16. Pragmatic Trial
    17. Propensity Score Methods
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    Post-Market

    0 / 22 studied

    Surveillance, vigilance, recalls, and lifecycle management.

    Step 1: Foundations (8)

    1. Post-Market Surveillance (PMS)
    2. Medical Device Vigilance
    3. Field Safety Corrective Action (FSCA)
    4. Post-Market Clinical Follow-up (PMCF)
    5. Medical Device Reporting (FDA) (MDR)
    6. FDA Recall Classifications I, II, III
    7. Annual Report (PMA)
    8. Periodic Safety Update Report (PSUR)
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    Step 2: Intermediate (7)

    1. PSUR (IVDR Specific)
    2. Field Action vs Recall
    3. Global Unique Device Identification Database (GUDID)
    4. Medical Device Recall
    5. Post-Market Performance Follow-up (PMPF)
    6. 5-Day Report
    7. Section 522 Postmarket Surveillance (Section 522)
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    Step 3: Advanced (7)

    1. Trend Reporting (MDR/MIR)
    2. Customer Notification Letter
    3. Electronic Medical Device Reporting (eMDR)
    4. Health Hazard Evaluation (HHE)
    5. Manufacturer Incident Report (MIR)
    6. Post-Market Surveillance Plan
    7. Removal vs Correction (21 CFR 806)
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