eQMS Requirements Checklist for Medical Devices 2025
147-Point Assessment for Medical Device Quality Management Systems
Covers: FDA 21 CFR 820 | ISO 13485:2016 | EU MDR | MDSAP
What This eQMS Requirements Checklist Helps You Achieve
Building a fully compliant electronic Quality Management System (eQMS) is one of the most important steps for any medical device manufacturer entering regulated markets. This checklist has been created to help startups, scale-ups and established companies understand exactly what regulators expect under EU MDR/IVDR, FDA 21 CFR 820, and ISO 13485:2016.
Whether you are preparing for CE marking, planning a QMS upgrade, or transitioning from a paper-based system, this page provides a clear, actionable overview of the core eQMS requirements:
- Document control and electronic record management
- Design and development procedures
- Risk management and traceability
- Supplier and production controls
- Post-market surveillance (PMS) and vigilance
- Audit readiness and continuous improvement
- Data integrity and system validation for software-based QMS tools
Each requirement is mapped to its regulatory source, allowing you to understand exactly which obligations apply and how they align across MDR, FDA, and ISO standards. This makes it easier to identify gaps and build an eQMS that meets global expectations — without wasting time on unnecessary paperwork.
This checklist is especially useful for medical device startups, digital health developers, and manufacturers beginning their compliance journey. By tracking your progress directly on this page, you can move efficiently toward a fully compliant, audit-ready eQMS that supports safe, effective, and reliable medical device development.
Why a Strong eQMS Matters for Medical Device Companies
A well-structured eQMS does more than satisfy regulators. It reduces development risk, improves product quality, speeds up certification timelines, and helps organizations scale responsibly. Companies with a robust eQMS experience:
- Faster Notified Body and FDA engagement
- Fewer non-conformities in audits
- Stronger documentation for technical files and regulatory submissions
- Better traceability and risk-benefit evidence
- Increased investor confidence and operational predictability
If you are building a new quality management system or improving an existing one, this checklist provides a practical foundation for achieving global medical device compliance with clarity and confidence.
Total Items
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1. Management Responsibility
Quality Policy & Objectives 8 items
- Documented quality policy signed by top management
- Quality objectives with measurable targets
- Management representative appointed with defined authority
- Person Responsible for Regulatory Compliance (PRRC) designated
- Organizational structure and responsibilities documented
- Resource allocation for QMS maintenance
- Management review procedure established
- Management review conducted at planned intervals (min. annually)
2. Document Control
Document Management System 12 items
- Document control procedure (SOP-001 or equivalent)
- Master document list maintained
- Document approval process before issue
- Document review and update process
- Version control system implemented
- Obsolete document control
- External document control (standards, regulations)
- Document retention periods defined
- Electronic document control validation (if applicable)
- Document distribution control
- Document change control process
- Quality manual maintained and current
3. Design Controls
Design and Development 20 items
- Design control procedure covering all phases
- Design and development planning
- Design input requirements documented
- Design output documentation
- Design review at appropriate stages
- Design verification protocols and reports
- Design validation protocols and reports
- Design transfer procedures
- Design change control process
- Design history file (DHF) maintained
- Risk management integrated into design
- Usability engineering file
- Software development lifecycle (if applicable)
- Clinical evaluation planning
- Biocompatibility assessment
- Packaging validation
- Sterilization validation (if applicable)
- Shelf life determination
- Transportation validation
- Design review board established
4. Risk Management
ISO 14971 Requirements 15 items
- Risk management plan for each device
- Risk management procedure aligned with ISO 14971
- Risk analysis conducted (FMEA, FTA, etc.)
- Risk evaluation criteria defined
- Risk control measures implemented
- Residual risk evaluation
- Risk/benefit analysis documented
- Risk management report completed
- Production and post-production information feedback
- Software risk analysis (if applicable)
- Cybersecurity risk assessment (if applicable)
- Use error risk analysis
- Risk management file maintained
- Risk review at defined intervals
- Risk communication to users (IFU, labeling)
5. Production and Process Controls
Manufacturing Controls 18 items
- Production planning and control procedures
- Process validation for special processes
- Work instructions for production
- Equipment qualification (IQ/OQ/PQ)
- Calibration of medical equipment program
- Preventive maintenance program
- Environmental control and monitoring
- Contamination control procedures
- Personnel hygiene requirements
- Material identification and traceability
- In-process inspection procedures
- Final inspection and testing
- Batch/lot release procedures
- Device history record (DHR) requirements
- Unique device identification (UDI) implementation
- Statistical techniques defined (sampling plans)
- Rework procedures documented
- Software validation (manufacturing software)
6. Non-Conformance and CAPA
Deviation Management & Corrective Actions 16 items
- Non conformance report procedure established
- Non-conforming product identification
- Segregation of non-conforming product
- Investigation procedures
- Disposition authority defined
- CAPA (Corrective and Preventive Action) system
- Root cause analysis methods defined
- Effectiveness verification of CAPAs
- Deviation management process documented
- Trend analysis of non-conformances
- Management review of CAPA system
- Rework validation requirements
- Scrap procedures and records
- Customer notification procedures (if required)
- Regulatory reporting for field actions
- CAPA tracking and metrics
7. Purchasing and Supplier Controls
Supply Chain Management 12 items
- Supplier evaluation and selection criteria
- Approved supplier list maintained
- Purchasing data requirements defined
- Incoming inspection procedures
- Supplier agreements/quality agreements
- Supplier audit program
- Supplier performance monitoring
- Critical component controls
- Change notification requirements
- Supplier non-conformance handling
- Verification of purchased product
- Supplier risk assessment
8. Training and Competence
Personnel Requirements 10 items
- Training procedure established
- Job descriptions with qualification requirements
- Training needs assessment
- Training records maintained
- Effectiveness evaluation of training
- GMP training for production personnel
- Regulatory training program
- Competency assessments
- Consultant qualification (if used)
- Training matrix maintained
9. Post-Market Surveillance
Market Surveillance & Vigilance 14 items
- Post-market surveillance plan
- Complaint handling procedure
- Complaint investigation process
- Vigilance reporting procedures (MDR, adverse events)
- Periodic safety update reports (PSUR)
- Post-market clinical follow-up (PMCF) plan
- Field safety corrective action (FSCA) procedures
- Recall procedures
- Trending of post-market data
- Customer feedback system
- Literature monitoring process
- Registry participation (if applicable)
- Summary of safety and performance (SSCP)
- Post-market surveillance report
10. Internal Audit and Improvement
Quality Assurance 8 items
- Internal audit procedure
- Annual audit schedule
- Qualified internal auditors
- Audit reports and follow-up
- Management review inputs/outputs
- Quality metrics and KPIs
- Continuous improvement process
- Customer satisfaction monitoring
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eQMS Implementation Complete
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This checklist provides general guidance based on common regulatory requirements as of 2025. Always consult current regulations and consider professional advice for your specific situation.
Use this as a comprehensive guide to track your progress towards implementing a fully compliant eQMS for medical device manufacturing.