SOP Deployment

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Summary

This Standard Operating Procedure (SOP) establishes comprehensive processes for production, deployment, installation, and integration of medical device software into customer environments. It ensures that validated software builds are properly installed, configured, and monitored while maintaining compliance with quality management requirements for production and service provision.

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Why is SOP Deployment important?

Deployment control is critical because medical device software must maintain its validated state when moved from development environments to customer production systems. Even properly validated software can fail to perform as intended if deployment processes introduce configuration errors, infrastructure incompatibilities, or validation gaps.

This SOP is essential because deployment represents the transition point where theoretical validation becomes real-world performance. Without controlled deployment processes, validated software might be incorrectly installed, improperly configured, or placed in environments that compromise its safety and effectiveness. Regulatory authorities require manufacturers to maintain control over production and service provision, including installation and integration activities.

Infrastructure qualification ensures that customer environments can properly support your medical device software, while deployment monitoring provides ongoing verification that devices continue to operate as intended in their production environments.

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Regulatory Context

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Guide

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Understanding Deployment Scope and Risk Assessment

Deployment complexity varies significantly based on your device type, customer environment, and integration requirements. Simple deployments might involve installing software on standard computing platforms with minimal configuration. Complex deployments might require custom hardware interfaces, integration with existing clinical systems, or specialized infrastructure qualification.

Risk-based approach to deployment planning considers the potential impact of deployment failures on device safety and effectiveness. High-risk deployments require more rigorous qualification, testing, and monitoring procedures.

Infrastructure assessment determines whether customer environments can properly support your device. Evaluate computing resources, network requirements, security controls, backup systems, and integration interfaces needed for proper device operation.

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Implementing Build Control and Release Management

Validated build control ensures that only properly tested and approved software versions are deployed to customer environments. Establish clear criteria for release readiness including completion of verification and validation activities, approval of all required documentation, and confirmation of regulatory compliance.

Version traceability maintains clear records of which software versions are deployed where. Use unique version identifiers that connect deployed software to specific development records, test results, and approval documentation.

Configuration management documents any environment-specific settings or customizations required for proper device operation. Version control these configurations and maintain traceability to base software versions.

Release approval process requires appropriate authorization before deployment occurs. Ensure business teams verify correct versions are being deployed and have authority to approve customer-specific deployments.

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Establishing Infrastructure Qualification Procedures

Qualification requirements depend on infrastructure complexity and risk level. Well-defined, controlled environments (such as standard cloud platforms) may require minimal qualification if their characteristics are well-understood and validated during development. Custom or complex environments require formal qualification to ensure they can support device operation.

Deployment Evaluation Checklist provides systematic assessment of infrastructure requirements, qualification needs, installation procedures, and acceptance criteria. Complete this assessment before beginning deployment activities.

Installation qualification verifies that infrastructure can support device requirements including computing resources, network connectivity, security controls, and integration interfaces. Document qualification criteria and test results.

Performance qualification confirms that devices operate correctly in the qualified infrastructure. Establish acceptance criteria for device performance and functionality verification.

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Managing Installation and Integration Processes

Installation planning defines step-by-step procedures for deploying device software into customer environments. Include pre-installation requirements, installation sequence, configuration steps, and post-installation verification activities.

Pre-defined acceptance criteria establish clear standards for successful installation. Define measurable criteria for device functionality, performance, integration, and user access that must be met before considering installation complete.

Installation documentation records all activities performed during deployment including configuration settings, test results, identified issues, and resolution actions. This documentation supports troubleshooting and provides evidence of proper installation procedures.

Failure recovery procedures define actions to take when installations don’t meet acceptance criteria. Include rollback procedures, issue diagnosis methods, and escalation processes for complex problems.

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Implementing Deployment Monitoring and Measurement

Performance monitoring establishes ongoing surveillance of deployed device operation. This might include automated monitoring systems, regular performance reports, or manual check-ins with customers to verify continued proper operation.

Issue reporting channels ensure customers can quickly report device problems or performance issues. Establish clear communication procedures and response timeframes for different types of issues.

User training verification confirms that device users receive appropriate training before beginning device use. Training should cover device operation, safety precautions, and proper procedures as defined in Instructions for Use.

Customer support processes provide ongoing assistance for deployed devices including technical support, user questions, and performance optimization guidance.

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Managing Updates and Maintenance

Update deployment for existing installations requires careful planning to minimize disruption while ensuring continued device compliance. Evaluate whether updates require additional integration steps, infrastructure changes, or user retraining.

Change impact assessment determines the scope of validation and qualification required for software updates. Major changes may require repeating portions of the deployment qualification process.

Customer notification procedures ensure users are informed about updates, potential system downtime, and any required actions on their part. Provide appropriate advance notice and clear instructions.

Update verification confirms that deployed updates function correctly and maintain device compliance. Include regression testing appropriate to the scope of changes.

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Handling Device Removal and Data Management

Removal procedures ensure complete and secure device removal when customer contracts end or devices are replaced. Include verification that devices are fully non-operational and customer data is handled appropriately.

Data migration and archival processes protect customer data while complying with data protection regulations. Coordinate with customers to ensure their data needs are met during device removal.

GDPR compliance requires careful handling of personal data during deployment and removal activities. Ensure appropriate data protection measures are implemented throughout the device lifecycle.

Removal verification confirms that devices are completely removed from customer systems and no longer accessible or functional. Document removal activities and verify customer satisfaction with the process.

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Example

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Scenario

You’re deploying a cloud-based medical device software application to a hospital’s clinical environment. The software integrates with the hospital’s electronic medical record (EMR) system and requires specific security and performance configurations. Here’s how the deployment process applies:

Pre-Deployment Assessment: Complete Deployment Evaluation Checklist to assess hospital infrastructure including network security, EMR integration capabilities, user access controls, and backup systems. Determine that infrastructure qualification is required due to custom EMR integration.

Infrastructure Qualification: Verify hospital’s network meets security requirements, EMR integration APIs function correctly, required computing resources are available, and backup/disaster recovery systems are operational. Document qualification test results and acceptance criteria.

Installation Planning: Create detailed installation plan including software deployment sequence, EMR integration configuration, user account setup, security configuration, and performance verification procedures. Define specific acceptance criteria for each installation step.

Deployment Execution: Deploy validated software build v2.3.1 to hospital’s qualified infrastructure, configure EMR integration with proper authentication, set up user accounts and permissions, conduct installation verification testing.

Installation Verification: Confirm software operates correctly, EMR integration functions properly, users can access required functions, performance meets specifications, and security controls are active. Document all verification activities and results.

User Training and Go-Live: Provide user training per Instructions for Use, establish ongoing support procedures, activate monitoring and reporting systems, and formally transfer device to production status.

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Example Deployment Documentation

Installation Plan for Regional Medical Center:

• Software Version: MedDevice v2.3.1 (Build 2024.03.15.001)
• Target Environment: Hospital private cloud infrastructure
• EMR Integration: Epic EHR v2023.2 via HL7 FHIR API
• User Population: 50 clinicians across 3 departments

Infrastructure Qualification Results:

• Network security assessment: PASSED - Meets HIPAA requirements
• Computing resources: PASSED - 99.9% uptime, sufficient capacity
• EMR integration testing: PASSED - All required APIs functional
• Backup systems: PASSED - 24-hour recovery time objective met
• User authentication: PASSED - Single sign-on integration successful

Installation Verification Checklist:

• ✓ Software deployment completed successfully
• ✓ Database initialization and data migration verified
• ✓ EMR integration functional testing passed
• ✓ User access and permissions configured correctly
• ✓ Performance benchmarks met (response time <2 seconds)
• ✓ Security controls active and verified
• ✓ Monitoring and alerting systems operational

Post-Installation Activities:

• User training completed for all 50 clinicians
• Customer support contact information provided
• Monitoring dashboard access configured
• First month performance review scheduled
• Update notification procedures established

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Q&A