Every framework Xyreg checks against

Early cross-standard sanity check performed in Concept & Planning to confirm target markets, device classification, applicable core standards, and the absence of obvious platform-level gaps before design work starts.

Complete set of 65 ISO 13485:2016 requirements for medical device quality management systems.

Enterprise-level risk management process: organisational process definition, management responsibilities, and personnel qualification.

Device-specific risk management: risk management plan, hazard identification, risk analysis, evaluation, control measures, residual risk assessment, review, and post-production monitoring.

Application of usability engineering to medical devices per IEC 62366-1:2015+A1:2020.

Symbols to be used with information supplied by the manufacturer of medical devices per ISO 15223-1:2021.

Requirements for information supplied by the manufacturer with medical devices per ISO 20417:2021.

General requirements for basic safety and essential performance of medical electrical equipment. Covers electrical, mechanical, radiation and temperature hazards, PEMS, construction and ME systems.

Electromagnetic compatibility requirements and tests for medical electrical equipment and systems. Covers emissions, immunity, risk management for EMC, and accompanying documents.

Collateral standard for usability engineering of medical electrical equipment. Covers use specification, hazard-related use scenarios, formative and summative evaluation.

Software life cycle processes for medical device software. Covers development, maintenance, risk management, configuration management, and problem resolution.

Biological evaluation of medical devices — evaluation and testing within a risk management process per ISO 10993-1:2018.

Safety requirements for stationary training equipment. Covers general safety, stability, strength/durability, labelling, instructions, and display accuracy.

MDR Annex I General Safety and Performance Requirements — official requirements (Chapter I: 20 items).

Technical documentation requirements under EU MDR Annex II for comprehensive device documentation.

Conformity assessment procedures under EU MDR Annex III for device certification and CE marking.

Packaging and Packaging Waste Regulation (EU 2025/40) compliance checklist covering material restrictions, labelling, and ecodesign requirements for medical device packaging.

Comprehensive readiness checklist for listing a Digital Health Application (DiGA) in the BfArM directory under §139e SGB V, structured from the BfArM Fast-Track Guide and DiGAV.

Swiss Medical Devices Ordinance (MepV) aligned with EU MDR, covering conformity assessment and market surveillance requirements for Switzerland.

UK Medical Devices Regulations 2002 (as amended) under MHRA covering UKCA marking, conformity assessment, and post-market surveillance for the UK market.

FDA QMSR (effective 2 Feb 2026) incorporates ISO 13485:2016 by reference with retained Part 820 sections (820.1, 820.3, 820.7, 820.10, 820.35, 820.45). Replaces the standalone 21 CFR Part 820 QSR. Internal audits, supplier audits, and management reviews are now subject to FDA inspection.

Comprehensive FDA 21 CFR Part 820 Quality System Regulation compliance checklist covering all subparts and requirements for medical device manufacturers.

TGA regulatory framework for medical devices including conformity assessment, essential principles, and post-market requirements for the Australian market.

ANVISA Resolution RDC 751/2022 establishing requirements for registration, labelling, and good manufacturing practices for medical devices in Brazil.

Health Canada Medical Device Regulations SOR/98-282 covering device classification, licensing, and quality system requirements for the Canadian market.

NMPA regulatory framework for medical devices including registration, classification, and quality management system requirements for the Chinese market.

Central Drugs Standard Control Organisation Medical Device Rules 2017 covering registration, import licensing, and clinical investigation requirements for India.

Japanese Pharmaceutical and Medical Device Act covering approval, QMS, and post-market surveillance requirements administered by PMDA.

Korean Ministry of Food and Drug Safety Medical Device Act covering device classification, technical documentation, and GMP requirements for South Korea.

EU General Data Protection Regulation — audit-ready clause set covering principles, data subject rights, controller/processor obligations, international transfers, and enforcement-relevant articles.

Trust Services Criteria for security, availability, processing integrity, confidentiality and privacy of a service organisation.

Requirements for establishing, implementing, maintaining and continually improving an information security management system.

US Health Insurance Portability and Accountability Act privacy and security rules for protected health information.

Certifiable framework harmonising HIPAA, ISO 27001, NIST and other authorities into a single control set for healthcare data.

Requirements for an artificial intelligence management system, governing responsible development and use of AI.

Voluntary framework for managing risks in the design, development, use and evaluation of AI systems.

Consolidated US state data privacy requirements for handling personal information across jurisdictions.

A custom checklist for tracking reimbursement and market-access requirements specific to your device and target payers.

Build, validate and mandate your own corporate compliance checklists and SOP templates, then run gap analysis against them like any built-in standard.