Sample Document Library
Explore real examples of the regulatory documentation generated by MedReg Suite. Each sample demonstrates our AI-powered output quality and standards compliance.
SOP-001: CAPA Procedure
Corrective and Preventive Action
Complete CAPA procedure aligned with ISO 13485:2016 Clause 8.5.2/8.5.3. Includes root cause analysis methods, effectiveness verification, and documentation requirements.
GSPR Compliance Checklist
EU MDR Annex I - Class IIb Active Device
Comprehensive GSPR compliance matrix covering all 23 General Safety and Performance Requirements with applicability assessments and evidence references.
Clinical Evaluation Report
Orthopedic Knee Implant System
Full 12-section Clinical Evaluation Report per MEDDEV 2.7/1 Rev 4 with automated PubMed/Europe PMC literature search and evidence appraisal.
Complete QMS Package
SaMD Cardiology AI - 80+ Documents
Full ISO 13485 Quality Management System with all procedures, work instructions, forms, and templates. Organized by clause with cross-references.
Risk Management File
Class IIa Active Device with Software
Complete ISO 14971:2019 Risk Management File with FMEA hazard analysis, risk evaluation matrices, and comprehensive benefit-risk conclusion.
Internal Audit Plan
ISO 13485 Recertification Audit
Complete internal audit plan with schedule, process-based audit scope, detailed checklists, and multi-standard coverage.
Usability Engineering File
Infusion System with Touchscreen
IEC 62366-1 compliant Usability Engineering File with use specification, formative studies, and summative testing protocol.
Clinical Evaluation Plan
Surgical Robot System
Comprehensive Clinical Evaluation Plan per MDCG 2020-13 defining scope, literature search strategy, and clinical evidence requirements.
SOP Gap Analysis Report
Legacy QMS Compliance Review
Comprehensive gap analysis comparing existing SOPs against ISO 13485:2016 requirements with prioritized remediation recommendations.
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