SaMD Post-Market Surveillance: Ensuring Ongoing Safety and Effectiveness

 

Here’s a concise overview you can use for a post or presentation on "SaMD Post-Market Surveillance: Ensuring Ongoing Safety and Effectiveness", covering key insights and responsibilities:

🩺 SaMD Post-Market Surveillance: Ensuring Ongoing Safety and Effectiveness

Software as a Medical Device (SaMD) doesn’t stop evolving once it’s launched. Post-market surveillance (PMS) ensures the software continues to meet safety, effectiveness, and regulatory requirements throughout its lifecycle.

🔍 Key Post-Market Surveillance Activities:

  1. Real-World Performance Monitoring

    • Collect data on clinical outcomes and user feedback in real settings.

    • Detect unanticipated issues that didn’t arise during premarket trials.

  2. Vigilance & Adverse Event Reporting

    • Report and investigate incidents under regulatory guidelines (e.g., FDA, MDR).

    • Ensure rapid updates or recalls when safety risks are identified.

  3. Periodic Safety Updates (PSURs)

    • Required in regions like the EU MDR: Summarize benefit-risk analysis, updates, and PMS findings.

  4. Software Updates & Change Management

    • Manage and validate patches, upgrades, and algorithm modifications.

    • Document changes with traceability and regulatory compliance.

  5. User Feedback & Continuous Improvement

    • Integrate user-reported issues and suggestions into iterative product improvements.

📊 Why It Matters:

  • Maintains patient trust and safety

  • Reduces regulatory risk and liability

  • Supports clinical validation in evolving environments

  • Enables AI/ML-driven SaMD to remain adaptive and compliant

Visit :  Akra (Akra AI) | Software As a Medical Device (SaMD)


Akra : #1 Powering Innovation with Software As a Medical Device | AI Powered Compliance and Validation for Healthcare Software | Innovators in AI-Powered Healthcare Compliance and Validation | Akra | Akra AI | Akra -Software as a Medical Device | Akra-Software as a Medical Device (SaMD)| Akra -SaMD | Akra | Software As a Medical Device ( SaMD) | Akra

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