MedTech glossary
Sources
Review sources & claimsOfficial laws, guidance, standards and public resources cited across the glossary. Citations may support regulatory context rather than every claim; some standards require paid access.
455 of 455 documents
Source methodologyAAMI
5 documentsCited by 18 terms
- ASTM F2503
- CAPA Effectiveness Check
- Essential Performance
- FDA Form 483
- Hazard, Hazardous Situation, and Harm
- ICH E6(R3) Good Clinical Practice (E6(R3))
- IEC 60601-1-2
- ISO 11137
- ISO 11607-1/-2
- ISO 14155
- ISO 31000
- Management Review
- Post-Production Information (Risk)
- Process FMEA vs Design FMEA (PFMEA / DFMEA)
- Risk Acceptability Matrix
- Servicing (21 CFR 820.200)
- Usability Engineering
- Use Specification
Cited by 1 term
- AAMI TIR57, Principles for Medical Device Security, Risk Management
array.aami.org
AAMI · Quality & Risk
Cited by 1 term
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AHRQ
1 documentCited by 1 term
AICPA & CIMA
3 documentsASQ
1 documentCited by 1 term
ASTM
2 documentsCited by 2 terms
Cited by 1 term
Canada (Justice / Health Canada)
1 documentCited by 1 term
CDISC
1 documentCited by 1 term
CISA
14 documentsCited by 1 term
Cited by 11 terms
- AAMI SW96
- AAMI TIR57
- FedRAMP (FedRAMP)
- Hardcoded Credentials
- HITRUST CSF (HITRUST)
- IEC 80001-1
- OWASP IoT and Embedded Application Security
- Refuse to Accept (Cybersecurity) (RTA (cyber))
- Secure Software Development Framework (SSDF)
- Supply-chain Levels for Software Artifacts (SLSA)
- Zero Trust Architecture (ZTA)
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CLSI
2 documentsCited by 1 term
CMS
29 documentsCited by 1 term
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CVE Program
1 documentCited by 1 term
Delaware government
3 documentsCited by 1 term
Cited by 1 term
- Delaware General Corporation Law (Title 8)
delcode.delaware.gov
Delaware government · Investment & Finance
Cited by 1 term
Ecma International
1 document- ECMA-424 CycloneDX Bill of Materials Standard
ecma-international.org
Ecma International · Cybersecurity
Cited by 1 term
ENISA
1 documentCited by 1 term
European Commission
21 documentsCited by 1 term
Cited by 1 term
- Commission Implementing Regulation designating EU RLs
health.ec.europa.eu
European Commission · Regulatory
Cited by 1 term
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- EIC Fund investment guidelines: milestone-based monitoring and investment process
eic.ec.europa.eu
European Commission · Investment & Finance
Cited by 3 terms
- EMA, Recommendation Paper on Decentralised Elements in Clinical Trials
health.ec.europa.eu
European Commission · Clinical & Trials
Cited by 1 term
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Cited by 14 terms
- Annual Report (PMA)
- Customer Notification Letter
- Electronic Medical Device Reporting (eMDR)
- EUDAMED
- FDA Recall Classifications I, II, III
- Field Action vs Recall
- Global Unique Device Identification Database (GUDID)
- Health Hazard Evaluation (HHE)
- Manufacturer Incident Report (MIR)
- Medical Device Recall
- Medical Device Vigilance
- Removal vs Correction (21 CFR 806)
- Section 522 Postmarket Surveillance (Section 522)
- Trend Reporting (MDR/MIR)
Cited by 47 terms
- 513(g) Request for Information (513(g))
- Accreditation Scheme for Conformity Assessment (ASCA)
- Additional Condition for Nonprescription Use (ACNU)
- AI Act Post-Market Monitoring
- AI Act Prohibited Practices
- AI Act Serious Incident Reporting
- AI Act Transparency Obligations
- Analytical Performance (IVDR)
- Benefit-Risk Determination
- Breakthrough Device Designation (BDD)
- Class III Device
- Clinical Performance (IVDR)
- Combination Product
- Device Master File (MAF)
- Emergency Use Authorization (EUA)
- Fundamental Rights Impact Assessment (FRIA)
- General Safety and Performance Requirements (IVDR) (GSPR)
- General-Purpose AI Model (GPAI)
- Humanitarian Device Exemption (HDE)
- IMDRF
- Importer and Distributor Obligations (EU)
- Indications for Use (IFU (statement))
- Instructions for Use (IFU)
- Intended Use
- ISO 20916
- IVDR Risk Classes A–D
- IVDR Transitional Provisions
- Medical Device User Fee Amendments (MDUFA)
- Ministry of Food and Drug Safety (Korea) (MFDS)
- Modular PMA
- National Medical Products Administration (NMPA)
- Performance Study Application (IVDR)
- Post-Market Performance Follow-Up (IVDR) (PMPF)
- Predicate Device
- Provider and Deployer (EU AI Act)
- Q-Submission (Pre-Submission) (Q-Sub / Pre-Sub)
- Request for Designation (RFD)
- Safer Technologies Program (STeP)
- Saudi Food and Drug Authority (SFDA)
- Scientific Validity (IVDR)
- Self-Test and Near-Patient Testing (IVDR)
- Substantial Equivalence (SE)
- Summary of Safety and Clinical Performance (SSCP)
- Swissmedic
- Third-Party Review of 510(k) (3P 510(k))
- UK Responsible Person (UKRP)
- WHO Prequalification (Diagnostics) (WHO PQ Dx)
- European Commission, Harmonised Standards for Medical Devices
single-market-economy.ec.europa.eu
European Commission · Standards
Cited by 1 term
- MDCG 2019-3 Interpretation of Article 54(2)(b) MDR (analogous)
health.ec.europa.eu
European Commission · Regulatory
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- MDCG Software Guidance
health.ec.europa.eu
European Commission · Cybersecurity · Post-Market · Regulatory · Software & AI
Cited by 46 terms
- Adversarial Robustness
- AI/ML-Enabled Medical Device
- Algorithm Change Protocol (ACP)
- Algorithmic Bias and Fairness
- Clinical Decision Support (CDS)
- Code Signing
- Common Specifications (CS)
- Common Weakness Enumeration (CWE)
- Companion Diagnostic (IVDR) (CDx)
- Customer Notification Letter
- Electronic Medical Device Reporting (eMDR)
- EU AI Act
- EU In Vitro Diagnostic Regulation (IVDR)
- EU Medical Device Regulation (MDR)
- EU Reference Laboratory (EURL) (EURL)
- Explainability and Interpretability
- Federated Learning
- Field Safety Corrective Action (FSCA)
- Foundation Model (Healthcare)
- Health Hazard Evaluation (HHE)
- Health Information Sharing and Analysis Center (H-ISAC)
- Healthcare and Public Health Cybersecurity Performance Goals (HPH-CPG)
- HSCC Joint Security Plan (HSCC JSP)
- ICS Medical Advisory (ICSMA)
- Locked vs. Adaptive Algorithm
- Manufacturer Incident Report (MIR)
- Medical Device Coordination Group Guidance (MDCG)
- Medical Device Recall
- Medical Device Vigilance
- NIST Cybersecurity Framework (NIST CSF)
- Over-the-Air Updates (OTA)
- Person Responsible for Regulatory Compliance (PRRC)
- Post-Market Performance Follow-up (PMPF)
- Post-Market Performance Follow-Up (IVDR) (PMPF)
- Predetermined Maintenance vs PCCP
- Secure-by-Design (Devices)
- Side-Channel Attack
- Software of Unknown Provenance (SOUP)
- Software Safety Case
- Software Safety Classification
- STRIDE Threat Model (STRIDE)
- Summary of Safety and Performance (IVDR) (SSP)
- Synthetic Data
- Total Product Lifecycle (TPLC)
- Trend Reporting (MDR/MIR)
- Unique Device Identification (UDI)
Cited by 1 term
European Investment Bank
1 documentCited by 1 term
European Union
1 documentCited by 1 term
European Union (EUR-Lex)
11 documentsCited by 12 terms
- 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
- EU AI Act
- Fundamental Rights Impact Assessment (FRIA)
- General-Purpose AI Model (GPAI)
- High-Risk AI System (EU AI Act)
- Provider and Deployer (EU AI Act)
- Systemic Risk (GPAI)
- EU MDR Chapter VII (Post-Market Surveillance)
eur-lex.europa.eu
European Union (EUR-Lex) · Post-Market
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- Regulation (EU) 2017/745
eur-lex.europa.eu
European Union (EUR-Lex) · Clinical & Trials · Post-Market · Quality & Risk · Regulatory · Standards
Cited by 14 terms
- Authorized Representative (EU) (EC REP)
- CE Mark
- Clinical Evaluation Consultation Procedure (CECP)
- Clinical Evaluation Plan (CEP)
- EU Medical Device Regulation (MDR)
- General Safety and Performance Requirements (GSPRs)
- Harmonised Standards
- Importer and Distributor Obligations (EU)
- MDR Article 117
- Notified Body (NB)
- Post-Market Surveillance Plan
- Risk Management
- Technical Documentation
- Trend Reporting (MDR/MIR)
- Regulation (EU) 2017/746 (IVDR)
eur-lex.europa.eu
European Union (EUR-Lex) · Clinical & Trials · Post-Market · Regulatory · Standards
Cited by 27 terms
- Analytical Performance (IVDR)
- Class D Batch Verification (IVDR)
- Clinical Performance (IVDR)
- Common Specifications (IVDR) (CS)
- Companion Diagnostic (IVDR) (CDx)
- EU In Vitro Diagnostic Regulation (IVDR)
- EU Reference Laboratory (EURL) (EURL)
- General Safety and Performance Requirements (IVDR) (GSPR)
- Genetic Testing Requirements (IVDR Article 4)
- In-House IVDs (Article 5(5))
- ISO 17511
- IVDR Conformity Assessment Routes
- IVDR Legacy Device
- IVDR Performance Evaluation
- IVDR Risk Classes A–D
- Metrological Traceability (IVDR)
- Notified Body Scrutiny (IVDR Class D)
- Performance Study (IVDR)
- Performance Study Application (IVDR)
- Post-Market Performance Follow-up (PMPF)
- Post-Market Performance Follow-Up (IVDR) (PMPF)
- Post-Market Surveillance Plan (IVDR)
- PSUR (IVDR Specific)
- Scientific Validity (IVDR)
- Self-Test and Near-Patient Testing (IVDR)
- Summary of Safety and Performance (IVDR) (SSP)
- Technical Documentation
- Regulation (EU) 2023/607 (MDR transition extension)
eur-lex.europa.eu
European Union (EUR-Lex) · Regulatory
Cited by 1 term
- Regulation (EU) 2024/1860 (transition amendment)
eur-lex.europa.eu
European Union (EUR-Lex) · Regulatory
- Regulation (EU) 2026/1744: amended AI Act application dates
eur-lex.europa.eu
European Union (EUR-Lex) · Regulatory · Software & AI
- Regulation (EU) No 1025/2012 on European Standardisation
eur-lex.europa.eu
European Union (EUR-Lex) · Standards
Cited by 1 term
FASB
2 documentsCited by 1 term
- FASB ASU 2017-11: down-round price-adjustment features (accounting context)
fasb.org
FASB · Investment & Finance
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FDA
127 documentsCited by 1 term
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- Deciding When to Submit a 510(k) for a Software Change to an Existing Device
www.fda.gov
FDA · Cybersecurity
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- AAMI TIR45 (TIR45)
- Adversarial Robustness
- AI Imaging Software
- AI/ML-Enabled Medical Device
- Data Governance (AI/ML)
- Generative AI in Medical Devices
- Good Machine Learning Practice (GMLP)
- Interoperability
- Locked vs. Adaptive Algorithm
- MLOps for Medical Devices (MLOps)
- Model Card
- Model Drift Monitoring
- ONC HTI-1 / HTI-2
- Predetermined Change Control Plan (PCCP)
- Software as a Medical Device (SaMD)
- Software in a Medical Device (SiMD)
- Software Maintenance Plan
Cited by 19 terms
- Adaptive Trial Design
- Adverse Event (AE)
- Analytical Sensitivity
- Bayesian Trial Design
- Clinical Investigation Plan (CIP)
- Composite Endpoint
- Core Laboratory
- Early Feasibility Study (EFS)
- IDE Annual Progress Report
- Investigational Device Exemption (IDE)
- Limit of Detection / Limit of Quantitation (LoD / LoQ)
- Master Protocol (Basket / Umbrella / Platform)
- Performance Study (IVDR)
- Pivotal Trial
- Pragmatic Trial
- Real-World Data (RWD)
- Serious Adverse Event (SAE)
- Surrogate Endpoint
- Use Error
Cited by 15 terms
- Bill of Materials (BOM)
- Cleanroom Classes (ISO 14644)
- Counterfeit Parts and Suspect Components
- Design Transfer
- Device History Record (DHR)
- Device Master Record (DMR)
- Endotoxin Testing (LAL)
- Engineering Change Order / Notice (ECO / ECN)
- MRP and ERP Systems (MRP / ERP)
- Pre-Approval Inspection (PAI)
- Process Capability (Cp/Cpk) and SPC
- Process Capability and Cpk
- Process Validation
- Supplier Controls
- UDI-DI vs. UDI-PI
Cited by 47 terms
- 510(k) Summary vs 510(k) Statement
- 513(g) Request for Information (513(g))
- Abbreviated 510(k)
- Accreditation Scheme for Conformity Assessment (ASCA)
- AI Act Conformity Assessment (Medical Devices)
- AI Act Post-Market Monitoring
- AI Act Serious Incident Reporting
- AI Act Transparency Obligations
- ANVISA (ANVISA)
- Class III Device
- Clinical Performance (IVDR)
- Common Specifications (IVDR) (CS)
- Device Master File (MAF)
- Electronic Instructions for Use (eIFU)
- EU Reference Laboratory (EURL) (EURL)
- EUDAMED
- FDA Recognized Consensus Standards
- Fundamental Rights Impact Assessment (FRIA)
- General Controls
- General Safety and Performance Requirements (IVDR) (GSPR)
- Health Canada Medical Device Licence (MDL)
- IMDRF
- Importer and Distributor Obligations (EU)
- Instructions for Use (IFU)
- ISO 20916
- IVDR Legacy Device
- IVDR Risk Classes A–D
- Labeling
- Letter to File (LTF)
- Medical Device Coordination Group Guidance (MDCG)
- Metrological Traceability (IVDR)
- MHRA / UKCA Marking (MHRA / UKCA)
- Ministry of Food and Drug Safety (Korea) (MFDS)
- National Medical Products Administration (NMPA)
- Person Responsible for Regulatory Compliance (PRRC)
- Predicate Device
- Provider and Deployer (EU AI Act)
- Q-Submission (Pre-Submission) (Q-Sub / Pre-Sub)
- Request for Designation (RFD)
- Safer Technologies Program (STeP)
- Saudi Food and Drug Authority (SFDA)
- Scientific Validity (IVDR)
- Special 510(k) (Special 510(k))
- Special Controls
- Systemic Risk (GPAI)
- Third-Party Review of 510(k) (3P 510(k))
- UK Responsible Person (UKRP)
Cited by 23 terms
- Biocompatibility
- CAPA Effectiveness Check
- Change Control
- Complaint Handling
- Design History File (DHF)
- Document Control
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Internal Audit
- IQ / OQ / PQ
- Management Representative
- Nonconformance (NCR) (NCR)
- Production and Process Controls
- Quality Manual
- Quality System Regulation (QSR / 21 CFR 820)
- Risk Management File (RMF)
- Shelf Life
- Summative vs. Formative Evaluation
- Training Records
- Use-Related Risk Analysis (URRA)
- Validation Master Plan (VMP)
- Verification & Validation (V&V)
- Warning Letter
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- FDA Content of Premarket Submissions for Device Software Functions (2023)
www.fda.gov
FDA · Software & AI
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Cited by 29 terms
- AAMI TIR57
- AAMI TIR97 (TIR97)
- Brainjacking
- Code Signing
- Coordinated Vulnerability Disclosure (CVD)
- Cryptographic Agility
- CycloneDX
- Hardcoded Credentials
- HSCC Joint Security Plan (HSCC JSP)
- IEC 81001-5-1
- Legacy Device Cybersecurity
- Medhacking
- Medjacking
- NIST Cybersecurity Framework (NIST CSF)
- Over-the-Air Updates (OTA)
- Patchability
- Penetration Testing
- Premarket Cybersecurity Submission
- Refuse to Accept (Cybersecurity) (RTA (cyber))
- SAST and DAST
- Section 524B of the FD&C Act (524B)
- Secure Boot
- Secure Product Development Framework (SPDF)
- Side-Channel Attack
- Software of Unknown Provenance (SOUP)
- Software Safety Case
- SPDX (SPDX)
- STRIDE Threat Model (STRIDE)
- Threat Modeling
Cited by 1 term
- FDA Design Control Guidance for Medical Device Manufacturers (withdrawn February 2026, archived copy linked by FDA)
www.fda.gov
FDA · Quality & Risk
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- FDA Guidance, Design Considerations for Pivotal Clinical Investigations for Medical Devices
www.fda.gov
FDA · Clinical & Trials
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- FDA Guidance, Reprocessing Medical Devices in Health Care Settings (2015)
www.fda.gov
FDA · Market Segments
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- 5-Day Report
- Field Safety Corrective Action (FSCA)
- Manufacturer Incident Report (MIR)
- Medical Device Reporting (FDA) (MDR)
- Medical Device Vigilance
- Periodic Safety Update Report (PSUR)
- Post-Market Clinical Follow-up (PMCF)
- Post-Market Performance Follow-up (PMPF)
- Post-Market Surveillance Plan
- PSUR (IVDR Specific)
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- FDA Postmarket Management of Cybersecurity in Medical Devices (2016)
www.fda.gov
FDA · Cybersecurity · Industry Bodies
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Cited by 15 terms
- 5-Day Report
- Annual Report (PMA)
- FDA Recall Classifications I, II, III
- Field Action vs Recall
- Field Safety Corrective Action (FSCA)
- Global Unique Device Identification Database (GUDID)
- Medical Device Recall
- Medical Device Reporting (FDA) (MDR)
- Periodic Safety Update Report (PSUR)
- Post-Market Clinical Follow-up (PMCF)
- Post-Market Surveillance (PMS)
- Post-Market Surveillance Plan
- PSUR (IVDR Specific)
- Removal vs Correction (21 CFR 806)
- Section 522 Postmarket Surveillance (Section 522)
Cited by 1 term
- FDA Recognized Consensus Standards
www.accessdata.fda.gov
FDA · Cybersecurity · Regulatory · Software & AI · Standards
Cited by 2 terms
- FDA registration and listing: commercial distribution (regulatory context)
www.fda.gov
FDA · Commercialization
Cited by 1 term
- FDA Safety Communication on Unauthorized Automated Insulin Dosing Systems (2019)
www.fda.gov
FDA · Cybersecurity
Cited by 1 term
Cited by 15 terms
- AI/ML-Enabled Medical Device
- Algorithm Change Protocol (ACP)
- Digital Therapeutic (DTx)
- Digital Therapeutics (DTx)
- Explainability and Interpretability
- Federated Learning
- Good Machine Learning Practice (GMLP)
- Interoperability
- Locked vs. Adaptive Algorithm
- MLOps for Medical Devices (MLOps)
- Model Card
- Model Drift Monitoring
- ONC HTI-1 / HTI-2
- Software as a Medical Device (SaMD)
- Total Product Lifecycle (TPLC)
- FDA scientific communications on unapproved uses of approved/cleared products (guidance pending implementation)
www.fda.gov
FDA · Commercialization
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- FDA, Cynosure (MonaLisa Touch) Untitled Letter on Vaginal Rejuvenation Claims (July 2018)
www.fda.gov
FDA · Market Segments
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- Hardware Root of Trust (HRoT)
- HITECH Act (HITECH)
- HITRUST CSF (HITRUST)
- IMDRF Principles and Practices for Medical Device Cybersecurity
- ISO/IEC 27001 (ISO 27001)
- NIST SP 800-53 / 800-171 (NIST 800-53/171)
- PHI and ePHI
- Postmarket Cybersecurity Management
- Premarket Cybersecurity Submission
- Section 524B of the FD&C Act (524B)
- Secure Boot
- SOC 2
- Software Bill of Materials (SBOM)
- Supply-chain Levels for Software Artifacts (SLSA)
- Threat Modeling
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FDA / NIH (GUDID)
1 documentCited by 1 term
FIRST
1 documentCited by 1 term
FTC
2 documentsCited by 1 term
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GSA / FedRAMP
4 documentsCited by 1 term
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HHS
12 documentsCited by 1 term
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HHS Office of Inspector General
1 documentHRSA
3 documentsCited by 1 term
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ICH
6 documentsCited by 1 term
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Cited by 25 terms
- Adaptive Trial Design
- ALCOA+
- Blinding and Masking
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Data Safety Monitoring Board (DSMB)
- Decentralized Clinical Trial (DCT)
- Feasibility Study
- First-in-Human Study (FIH)
- Human Factors Engineering (HFE)
- ICH E6 Good Clinical Practice (GCP)
- IDE Supplement
- Informed Consent
- Institutional Review Board (IRB)
- Intent-to-Treat vs Per-Protocol (ITT / PP)
- Lost to Follow-up
- Minimal Clinically Important Difference (MCID)
- Non-Inferiority Trial
- Primary and Secondary Endpoints
- Propensity Score Methods
- Protocol Deviation
- Real-World Evidence (RWE)
- Sham Control
- Source Data Verification (SDV)
- Unanticipated Adverse Device Effect (UADE)
IEC
8 documentsCited by 1 term
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IETF / RFC Editor
1 documentCited by 1 term
IFRS Foundation
1 document- IFRS 3: contingent acquisition consideration (accounting context)
www.ifrs.org
IFRS Foundation · Investment & Finance
Cited by 2 terms
IMDRF
7 documentsCited by 16 terms
- Bioburden
- Container Closure Integrity (CCI)
- Design Transfer
- Device Master Record (DMR)
- Endotoxin Testing (LAL)
- Lot Traceability
- Pre-Approval Inspection (PAI)
- Process Capability (Cp/Cpk) and SPC
- Process Capability and Cpk
- Process Validation
- Scrap Rate and Yield
- Stability Testing
- Sterilization
- Supplier Controls
- Technology Transfer (Manufacturing)
- UDI-DI vs. UDI-PI
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- 513(g) Request for Information (513(g))
- Accreditation Scheme for Conformity Assessment (ASCA)
- AI Act Prohibited Practices
- AI Act Technical Documentation (Annex IV)
- Analytical Performance (IVDR)
- ANVISA (ANVISA)
- Authorized Representative (EU) (EC REP)
- Benefit-Risk Determination
- Breakthrough Device Designation (BDD)
- Class D Batch Verification (IVDR)
- Class III Device
- Common Specifications (CS)
- Companion Diagnostic (IVDR) (CDx)
- De Novo Classification Request (De Novo)
- Device Reclassification Petition
- General Safety and Performance Requirements (GSPRs)
- Genetic Testing Requirements (IVDR Article 4)
- High-Risk AI System (EU AI Act)
- Humanitarian Device Exemption (HDE)
- In-House IVDs (Article 5(5))
- Indications for Use (IFU (statement))
- Intended Use
- IVDR Conformity Assessment Routes
- Labeling
- MDR Article 117
- Medical Device User Fee Amendments (MDUFA)
- Ministry of Food and Drug Safety (Korea) (MFDS)
- Modular PMA
- NMPA Innovative Medical Device Pathway
- Pharmaceuticals and Medical Devices Agency (PMDA)
- PMA Supplement Types
- Post-Market Surveillance Plan (IVDR)
- Real-Time PMA Supplement Review
- Request for Designation (RFD)
- Saudi Food and Drug Authority (SFDA)
- Self-Test and Near-Patient Testing (IVDR)
- Special Controls
- Substantial Equivalence (SE)
- Summary of Safety and Clinical Performance (SSCP)
- Summary of Safety and Performance (IVDR) (SSP)
- Swissmedic
- Therapeutic Goods Administration (TGA)
- Third-Party Review of 510(k) (3P 510(k))
- WHO Prequalification (Diagnostics) (WHO PQ Dx)
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- Adversarial Robustness
- Algorithmic Bias and Fairness
- Clinical Decision Support (CDS)
- Data Governance (AI/ML)
- Datasheets for Datasets
- EU AI Act
- Foundation Model (Healthcare)
- Generative AI in Medical Devices
- Medical Device Data System (MDDS)
- Predetermined Change Control Plan (PCCP)
- Predetermined Maintenance vs PCCP
- Secure-by-Design (Devices)
- Software as a Medical Device (SaMD)
- Software in a Medical Device (SiMD)
- Software Maintenance Plan
- Synthetic Data
ISO
33 documentsCited by 2 terms
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Cited by 1 term
- IEC 81001-5-1: Health software - Security activities in the product life cycle
www.iso.org
ISO · Cybersecurity
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Cited by 33 terms
- Bill of Materials (BOM)
- Bioburden
- Biocompatibility
- CAPA Effectiveness Check
- Change Control
- Cleanroom Classes (ISO 14644)
- Container Closure Integrity (CCI)
- Counterfeit Parts and Suspect Components
- Design Controls
- Design History File (DHF)
- Device History Record (DHR)
- Engineering Change Order / Notice (ECO / ECN)
- Failure Mode and Effects Analysis (FMEA)
- Hazard, Hazardous Situation, and Harm
- Lot Traceability
- MRP and ERP Systems (MRP / ERP)
- Nonconformance (NCR) (NCR)
- Post-Production Information (Risk)
- Process Capability (Cp/Cpk) and SPC
- Process FMEA vs Design FMEA (PFMEA / DFMEA)
- Process Validation
- Production and Process Controls
- Quality Manual
- Quality System Regulation (QSR / 21 CFR 820)
- Risk Management
- Scrap Rate and Yield
- Stability Testing
- Sterilization
- Technology Transfer (Manufacturing)
- Use Specification
- Use-Related Risk Analysis (URRA)
- Validation Master Plan (VMP)
- Verification & Validation (V&V)
Cited by 26 terms
- Adverse Event (AE)
- ALCOA+
- Analytical Sensitivity
- Blinding and Masking
- Clinical Evaluation Report (CER)
- Clinical Investigation Plan (CIP)
- Early Feasibility Study (EFS)
- Feasibility Study
- First-in-Human Study (FIH)
- ICH E6 Good Clinical Practice (GCP)
- Informed Consent
- Institutional Review Board (IRB)
- Investigational Device Exemption (IDE)
- Investigator Brochure (IB)
- ISO 14155
- Limit of Detection / Limit of Quantitation (LoD / LoQ)
- Lost to Follow-up
- Minimal Clinically Important Difference (MCID)
- Performance Study (IVDR)
- Pivotal Trial
- Real-World Evidence (RWE)
- Serious Adverse Event (SAE)
- Sham Control
- Source Data Verification (SDV)
- Surrogate Endpoint
- Use Error
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Joint Commission
1 document- Joint Commission NPSG.06.01.01 Alarm Safety
www.jointcommission.org
Joint Commission · Market Segments
Cited by 1 term
LINDDUN
2 documentsLinux Foundation / SPDX
1 documentCited by 2 terms
MITRE
14 documentsCited by 1 term
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- Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook (MITRE, 2022)
www.mitre.org
MITRE · Cybersecurity
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NICE
4 documentsCited by 1 term
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NIH
3 documentsCited by 1 term
Cited by 2 terms
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NIH / ClinicalTrials.gov
1 documentCited by 21 terms
- Adaptive Trial Design
- Adverse Event (AE)
- Bayesian Trial Design
- Case Report Form (CRF)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Clinical Investigation Plan (CIP)
- Composite Endpoint
- Data Safety Monitoring Board (DSMB)
- Electronic Data Capture (EDC)
- Human Factors Engineering (HFE)
- IDE Supplement
- Intent-to-Treat vs Per-Protocol (ITT / PP)
- Investigator Brochure (IB)
- Investigator-Initiated Trial (IIT)
- Propensity Score Methods
- Protocol Deviation
- Risk-Based Monitoring (RBM)
- Sample Size and Statistical Power
- Serious Adverse Event (SAE)
- Trial Master File (TMF)
NIST
19 documentsCited by 1 term
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NMPA
1 documentOASIS
1 documentCited by 1 term
OpenSSF / SLSA
3 documentsCited by 1 term
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OWASP
2 documentsCited by 1 term
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OWASP / CycloneDX
1 documentCited by 2 terms
PIC/S
1 documentCited by 1 term
PMDA
1 documentCited by 1 term
SAE International
1 documentCited by 1 term
SEC
17 documentsCited by 2 terms
Cited by 1 term
- SEC Final Rule 33-11265, SPACs, Shell Companies, and Projections
www.sec.gov
SEC · Investment & Finance
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- SEC Rule 701: employee equity compensation (regulatory context)
www.sec.gov
SEC · Investment & Finance
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Swissmedic
1 documentCited by 1 term
TGA
1 documentCited by 1 term
Trusted Computing Group
1 documentCited by 1 term
U.S. Congress
2 documentsCited by 1 term
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U.S. government (eCFR)
51 documentsCited by 1 term
- 21 CFR 312, Investigational New Drug Application
www.ecfr.gov
U.S. government (eCFR) · Clinical & Trials
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- 21 CFR 814.20, PMA content (incorporation by reference of master files)
www.ecfr.gov
U.S. government (eCFR) · Regulatory
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- 21 CFR Part 312.62, Investigator recordkeeping
www.ecfr.gov
U.S. government (eCFR) · Clinical & Trials
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- 42 CFR § 419.66 : Transitional pass-through payments: Medical devices
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
Cited by 1 term
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- 42 CFR 405.211: Coverage of items and services in FDA-approved IDE studies
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
Cited by 1 term
- 42 CFR 405.212: Medicare coverage IDE study criteria
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
Cited by 1 term
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- 42 CFR 412.60: DRG classification and weighting factors
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
Cited by 1 term
- 42 CFR 412.87: Additional payment for new medical services and technologies
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
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- 42 CFR 414.20: Formula for computing fee schedule amounts
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
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- 42 CFR 414.507: Payment for clinical diagnostic laboratory tests
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
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- 42 CFR 419.31: Ambulatory payment classification system
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
- 42 CFR 419.48: Excepted items and services; nonexcepted department payment
www.ecfr.gov
U.S. government (eCFR) · Reimbursement
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- FDA definition of a CRO in drug investigations (21 CFR 312.3)
www.ecfr.gov
U.S. government (eCFR) · Industry Bodies
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- HHS OIG group purchasing organization safe harbor (42 CFR 1001.952(j))
www.ecfr.gov
U.S. government (eCFR) · Commercialization
Cited by 1 term
- Quality System Regulation (21 CFR 820)
www.ecfr.gov
U.S. government (eCFR) · Manufacturing · Quality & Risk · Regulatory
Cited by 18 terms
- Change Control
- Complaint Handling
- Corrective and Preventive Action (CAPA)
- Design Controls
- Design History File (DHF)
- Design Transfer
- Device History Record (DHR)
- Device Master Record (DMR)
- Engineering Change Order / Notice (ECO / ECN)
- Lot Traceability
- Nonconformance (NCR) (NCR)
- Production and Process Controls
- Quality Management System (QMS)
- Quality System Regulation (QSR / 21 CFR 820)
- Servicing (21 CFR 820.200)
- Supplier Controls
- Technical Documentation
- Training Records
Cited by 1 term
U.S. government (Federal Register)
4 documents- FDA ACNU Final Rule (Dec 2024)
www.federalregister.gov
U.S. government (Federal Register) · Regulatory
Cited by 1 term
- HIPAA Security Rule NPRM (2024)
www.federalregister.gov
U.S. government (Federal Register) · Cybersecurity
Cited by 1 term
- Medicare Program; Transitional Coverage for Emerging Technologies (Final Notice)
www.federalregister.gov
U.S. government (Federal Register) · Reimbursement
Cited by 1 term
- QMSR Final Rule (Federal Register)
www.federalregister.gov
U.S. government (Federal Register) · Quality & Risk · Standards
U.S. government (genome.gov)
1 documentCited by 1 term
U.S. government (healthit.gov)
1 documentCited by 1 term
U.S. government (irs.gov)
2 documentsCited by 1 term
Cited by 1 term
U.S. government (sba.gov)
1 document- SBA market research: demand, market size and pricing (supporting context)
www.sba.gov
U.S. government (sba.gov) · Commercialization
Cited by 2 terms
U.S. government (sbir.gov)
1 documentCited by 1 term
U.S. government (uspto.gov)
1 documentCited by 1 term
U.S. government (whitehouse.gov)
2 documents- OMB M-22-09 Federal Zero Trust Strategy
www.whitehouse.gov
U.S. government (whitehouse.gov) · Cybersecurity
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U.S. House / U.S. Code
1 documentCited by 1 term
UK government / MHRA
2 documentsCited by 1 term
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USP
1 documentCited by 1 term
WHO
1 documentCited by 1 term