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Perform ISO 14971 Assessment using eAuditor

ISO 14971 is the international standard for the application of risk management to medical devices. It provides a comprehensive framework for identifying, evaluating, controlling, and monitoring risks associated with the use of medical devices throughout their entire lifecycle—from design and development to production, post-market surveillance, and decommissioning.

Performing an ISO 14971:2019 Assessment using eAuditor allows medical device manufacturers to comprehensively audit their risk management system (RMS) to ensure it meets the latest global standards for medical device safety and effectiveness. eAuditor enables this through digital checklists, real-time documentation, team collaboration, and analytics, supporting device lifecycle risk control—from design to post-market surveillance—while maintaining regulatory readiness.

1. Pre-Assessment Preparation Using eAuditor

1.1 Define Assessment Scope and Context

• Determine Coverage:
  • Evaluate risk processes across one or multiple device families.
  • Include all lifecycle phases: design, development, production, distribution, clinical use, and end-of-life.
• Clarify Audit Objectives:
  • Confirm integration of ISO 14971 into the product lifecycle.
  • Evaluate the consistency of risk control implementation and documentation.
  • Identify improvement areas in current risk controls and monitoring systems.

1.2 Review Existing Risk Management Documentation

Compile necessary documentation for pre-audit preparation:

• Product-specific Risk Management Plans (RMPs).
• Risk analysis reports using methods like FMEA, FTA, HACCP, etc.
• Hazard identification logs, including biological, electrical, software, and usability risks.
• Post-market surveillance reports and field safety notices.
• Benefit-risk analysis documentation.
• Corrective and preventive action (CAPA) records.
• Updated Risk Management Files (RMFs).

1.3 Create or Customize ISO 14971 Checklist in eAuditor

Structure the checklist according to ISO 14971’s lifecycle-based risk approach:

• Risk management planning
• Risk analysis and hazard identification
• Acceptability criteria and Risk evaluation
• Risk control and verification
• Evaluation of residual risks
• Benefit-risk analysis (if applicable)
• Post-market feedback and risk re-evaluation
• Risk documentation completeness

Checklist design:

• Use Yes/No/Partial ratings and free-text commentary fields.
• Embed file/photo upload sections (design drawings, lab test results, hazard logs).
• Use conditional logic for critical vs. non-critical risk items.
• Assign responsible persons, timelines, and priorities to findings.

2. Executing the ISO 14971 Audit Using eAuditor

2.1 Risk Management Planning Assessment

• Is a written Risk Management Plan in place for each product?
• Does it define:
  • Roles and responsibilities?
  • Risk acceptability criteria?
  • Methods for hazard identification, evaluation, and control?
  • Post-production monitoring strategy?

2.2 Risk Analysis and Hazard Identification

• Are all potential hazards identified for the device, including:
  • Intended use and foreseeable misuse?
  • Environmental, user interface, and system-level risks?
• Are biological, software-related, and electromagnetic interference risks addressed?
• Are usability engineering and human factors considered?

2.3 Risk Evaluation

• Is risk evaluated using probability × severity metrics?
• Are risk matrices standardized across products?
• Are unacceptable risks clearly flagged for mitigation?

2.4 Risk Control Implementation

• Are the following prioritized correctly?
  • Design modification (most effective)
  • Protective measures (e.g., alarms, enclosures)
  • User training/warnings (least preferred)
• Is control effectiveness verified (through testing or simulation)?
• Are risk controls validated and documented?

2.5 Evaluation of Residual Risks

• Are residual risks assessed after controls are applied?
• Have they been compared against the original risk acceptability matrix?
• Are further controls implemented if residual risk remains too high?

2.6 Benefit-Risk Analysis

• For non-acceptable residual risks, is there a documented analysis demonstrating:
  • That the medical benefit outweigh the risk?
  • Inclusion of clinical data or performance evidence?
• Is this benefit-risk profile communicated to users or clinicians?

2.7 Production and Post-Production Activities

• Is there a plan to collect feedback on product performance and safety?
  • Complaint logs
  • Field safety corrective actions (FSCA)
  • Recall data
• Are these used to update the RMF and trigger re-analysis when needed?
• Are signals (trend data, increased incident frequency) formally reviewed?

2.8 Risk Management File (RMF)

• Does the RMF contain:
  • RMP
  • Risk analyses, evaluations, and controls
  • Residual risk assessments
  • Justifications and review records
• Is the file version-controlled and reviewed at defined intervals?

3. Real-Time Features of eAuditor During ISO 14971 Assessment

3.1 Evidence Capture and Documentation

• Use tablets or mobile phones to collect:
  • Photos of devices, labeling, packaging, or instructions for use.
  • Screenshots of UI/software interfaces with usability risks.
  • Test results or hazard analysis reports.
• Upload supporting documents directly into audit forms.
• Use geotagging and timestamping to confirm audit location and time.
• Collect auditor sign-offs and digital approvals at each audit stage.

3.2 Assign and Track Corrective Actions

• Convert noncompliant findings into actionable tasks immediately.
• Assign to relevant departments (engineering, quality, regulatory).
• Include:
  • Risk type and clause reference
  • Required action
  • Deadline and responsible owner
• Track through the eAuditor Actions Dashboard.
• Attach evidence when complete (e.g., updated risk log, SOP revision).

4. Post-Audit Reporting and Monitoring in eAuditor

4.1 Generate a Professional Risk Assessment Report

• Include:
  • Compliance breakdown by ISO 14971 clause
  • Supporting attachments, photos, and evidence
  • Nonconformities and status of corrective actions
  • Overall audit score or risk compliance status
• Export as PDF, Excel, or online report for internal use or external reviewers (e.g., notified bodies)

4.2 Reassess and Close the Loop

• Use audit reports in management review meetings.
• Analyze the effectiveness of closed actions using follow-up audits.
• Flag recurring or critical findings for escalation.
• Update your risk analysis and RMF with lessons learned.

4.3 Use eAuditor Analytics for Insightful Decision Making

• View trends across devices, sites, or audit periods.
• Spot high-risk areas with frequent noncompliance.
• Track time to closure for CAPAs related to risk.
• Generate dashboards for internal presentations or certification bodies.

5. Recommended Checklist Sections for ISO 14971 in eAuditor

• Scope and context of device risk
• Risk acceptability criteria (thresholds, rationale)
• Hazard identification logs with reference numbers
• Method of risk evaluation (e.g., FMEA, HACCP)
• Risk control implementation logs
• Post-control residual risk review
• Evidence of benefit-risk trade-off decisions
• Production/post-production monitoring procedure
• Risk Management File completeness and control

6. Advantages of Using eAuditor for ISO 14971 Risk Management Audits

• Centralized and digitized auditing ensures all stakeholders have access to a single source of truth.
• Live collaboration allows engineering, QA, and regulatory teams to update findings and actions in real time.
• Data visualization tools help track risk areas, overdue actions, or recurring safety issues.
• Instant reporting simplifies documentation for regulators and accreditation bodies.
• Audit history and traceability support long-term lifecycle compliance and accountability.

Summary

Conducting an ISO 14971:2019 Risk Management Assessment using eAuditor empowers medical device manufacturers to systematically document, verify, and improve how they identify and control device risks. eAuditor streamlines risk reviews, accelerates issue resolution, and ensures traceable, audit-ready reporting—supporting not just compliance, but a safer, more efficient device lifecycle management approach.

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