| AI Findings inbox | Single queue where every AI proposal is approved by a human under PIN-signed ceremony. |
| Annex II / III (MDR) | Technical-file structure (II) and post-market-TF structure (III) under MDR. |
| Annex IX / X / XI (MDR) | Three NB conformity-assessment routes. |
| Annex IV (EU AI Act) | Technical documentation structure for high-risk AI systems. |
| Approval engine | Wrapper’s polymorphic approval mechanism covering 7 object types. |
| AuditSignature ledger | INSERT-only, hash-chained Part-11 signature store. |
| Basic UDI-DI | Device-group identifier under MDR Annex VI Part C §3.2. |
| CAPA | Corrective and Preventive Action; ISO 13485 §8.5.2 + FDA 21 CFR 820.100. |
| CE marking | EU market-access marking under MDR 2017/745. |
| CER / CEP | Clinical Evaluation Report / Plan; MDR Annex XIV. |
| Change-Management AI | Regulatory ripple-effect engine; 90+ rules. |
| CMRT | Conflict Minerals Reporting Template; Dodd-Frank §1502. |
| CycloneDX | SBOM format (OWASP); CycloneDX 1.5 current. |
| DHF / DMR / DHR | Design History File / Device Master Record / Device History Record. |
| DoC | Declaration of Conformity; MDR Art. 19 + Annex IV. |
| EU AI Act | EU Regulation 2024/1689; high-risk obligations effective 2 August 2026. |
| EU AR | EU Authorised Representative; MDR Art. 11. |
| EUDAMED | European Database on Medical Devices; six modules. |
| FDA QMSR | Replacement of 21 CFR 820 effective 2 February 2026, aligned with ISO 13485:2016. |
| FSCA / FSN | Field Safety Corrective Action / Notice; MDR Art. 89 + MDCG 2023-3. |
| GMLP | Good Machine Learning Practice; FDA/Health-Canada/MHRA joint principles (2021). |
| GSPR | General Safety and Performance Requirements; MDR Annex I. |
| GUDID | FDA Global Unique Device Identifier Database; 21 CFR 830. |
| HITL | Human-in-the-Loop; EU AI Act Art. 14 contract. |
| IEC 42001 | AI management-systems standard (2023). |
| IEC 62304 | Medical-device software lifecycle standard. |
| IEC 62366-1 | Medical-device usability engineering standard. |
| IEC 81001-5-1 | Health-software cybersecurity lifecycle standard (2021). |
| IFU | Instructions For Use; MDR Annex I §23 / 21 CFR 801. |
| ISMS | Information Security Management System; ISO 27001 construct. |
| ISO 13485 | Medical-device QMS standard (2016). |
| ISO 14971 | Medical-device risk-management standard (2019). |
| ISO 27001 / 27005 | Information-security management / risk standards (2022). |
| ISO/IEC 23894 | AI risk-management standard (2023). |
| KEV / EPSS | CISA Known Exploited Vulnerabilities catalog / Exploit Prediction Scoring System. |
| MDCG 2019-16 | Medical Device Coordination Group cybersecurity guidance. |
| MDCG 2023-3 | MDCG vigilance terms guidance. |
| MDR | EU Medical Device Regulation 2017/745. |
| MDSAP | Medical Device Single Audit Program. |
| MedWatch 3500A | FDA mandatory MDR submission form. |
| MHRA | UK Medicines and Healthcare products Regulatory Agency. |
| MIR | Manufacturer Incident Report; MDR Art. 87. |
| MTF | Master Technical File. |
| NB | Notified Body. |
| NCMR | Non-Conforming Material Report. |
| NIS2 | EU Directive 2022/2555 on network and information-security. |
| NIST CSF 2.0 | US Cybersecurity Framework. |
| OAI | FDA "Official Action Indicated" — adverse inspection classification. |
| ObjectApproval / ObjectJournal | Polymorphic approval entity and audit-trail entity in Wrapper. |
| OJEU | Official Journal of the European Union. |
| Part 11 | FDA 21 CFR Part 11 electronic records + signatures rule. |
| PCCP | Predetermined Change Control Plan; FDA final guidance 2024. |
| PMA | Pre-Market Approval; FDA pathway for Class III. |
| PMCF | Post-Market Clinical Follow-up; MDR Annex XIV Part B. |
| PMS / PMSR / PSUR | Post-Market Surveillance / Surveillance Report / Periodic Safety Update Report. |
| PRRC | Person Responsible for Regulatory Compliance; MDR Art. 15. |
| QES | Quality Event System. |
| REACH | EU Regulation (EC) 1907/2006. |
| Regulatory Health Score | Deterministic 0–100 audit-readiness gauge per device per regulator. |
| RoHS | EU Directive 2011/65/EU. |
| SaMD | Software as a Medical Device. |
| SBOM | Software Bill of Materials. |
| Smart Impact Mapper | Wrapper’s AI engine driving Change-Management AI. |
| SOC-2 | AICPA Trust Services Criteria attestation. |
| SOUP | Software of Unknown Provenance; IEC 62304 term. |
| SPDF | FDA Secure Product Development Framework. |
| SPDX | SBOM format alternative. |
| SRN | Single Registration Number; EUDAMED actor identifier. |
| SSCP | Summary of Safety and Clinical Performance; MDR Art. 32. |
| STRIDE / PASTA | Threat-modelling methodologies. |
| Technical File | MDR Annex II dossier. |
| Traceability Matrix | Requirements ↔ Risks ↔ Design ↔ Tests grid. |
| UDI / UDI-DI / Basic UDI-DI | Unique Device Identifier system. |
| UKCA | UK Conformity Assessed marking. |
| UKRP | UK Responsible Person; UK MDR 2002 Reg. 7A. |
| V&V | Verification & Validation. |
| 21 CFR Part 11 | FDA electronic records and signatures rule. |
| 21 CFR 820 | FDA Quality System Regulation (replaced by QMSR 2 Feb 2026). |
| 510(k) | FDA pathway for substantially-equivalent devices. |
