Deployment Evaluation Checklist
Summary
The Deployment Evaluation Checklist is a systematic assessment tool that evaluates the complexity and risks associated with deploying your medical device software in customer environments. This document helps determine whether additional deployment evaluation is required, establishes installation and monitoring procedures, and documents the successful deployment of your device to ensure ongoing safety and performance.
Why is Deployment Evaluation Checklist important?
Medical device software deployment introduces unique risks that don’t exist during development or testing phases. Real-world customer environments have varying infrastructure complexity, interdependencies, and potential failure modes that could compromise device safety and performance. The deployment evaluation ensures you have systematically assessed these risks and implemented appropriate controls before releasing your device to customers. This proactive approach helps prevent deployment-related incidents and demonstrates regulatory compliance with software lifecycle requirements.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Design controls (820.30) require validation in actual use environment
- Installation and servicing (820.200) must be controlled and documented
- Software validation guidance requires deployment environment consideration
- Cybersecurity guidance emphasizes secure deployment practices
Special attention required for:
- Network security requirements for connected devices
- Software validation in intended use environment
- Change control for deployment configuration differences
- Post-market surveillance of deployment-related issues
Under 21 CFR Part 820 (Quality System Regulation):
- Design controls (820.30) require validation in actual use environment
- Installation and servicing (820.200) must be controlled and documented
- Software validation guidance requires deployment environment consideration
- Cybersecurity guidance emphasizes secure deployment practices
Special attention required for:
- Network security requirements for connected devices
- Software validation in intended use environment
- Change control for deployment configuration differences
- Post-market surveillance of deployment-related issues
Under EU MDR 2017/745:
- GSPR 17 requires software reliability and performance in intended use
- EN 62304 mandates software deployment planning and execution
- IEC 80001-1 provides network security requirements for medical devices
- Post-market surveillance (Articles 83-86) must monitor deployment issues
Special attention required for:
- Infrastructure complexity assessment for patient safety impact
- Cybersecurity risk management in deployment environments
- Clinical evaluation of software performance in real-world settings
- Incident reporting for deployment-related safety issues
Guide
Infrastructure Complexity Assessment
The first critical step is evaluating your customer’s infrastructure complexity. Insignificant complexity environments are well-established with few interdependencies, robust backup systems, and very low risk of failures that could compromise device safety. Significant complexity environments have multiple interdependencies, medium to high risk of system failures, and potential for compromising device safety and performance. This assessment determines whether full deployment evaluation is required.
Customer Information Documentation
Document comprehensive customer contact information including technical contacts, company details, and communication preferences. This information is essential for ongoing support, incident response, and post-market surveillance activities. Ensure you have multiple contact methods and understand the customer’s organizational structure for device management.
Installation Planning and Execution
Develop a detailed installation plan that addresses the specific customer environment, including on-site versus remote installation approaches. Define clear acceptance criteria that must be met for successful installation, such as user authentication functionality, system startup verification, and basic operational tests. Document team member responsibilities, expected timelines, and contingency procedures for installation issues.
Monitoring and Measurement Strategy
Establish how you will monitor and measure your deployed device performance. Automatic monitoring through software telemetry, remote monitoring systems, or on-site equipment provides continuous oversight. Manual monitoring through customer communications, scheduled check-ins, or site visits offers direct feedback but requires more resources. Define monitoring frequency, key performance indicators, and escalation procedures for identified issues.
Deployment Documentation and Verification
Document the actual deployment process including installation success against acceptance criteria, any issues encountered, and resolution approaches. Record the specific software version deployed and verify that deployment occurred successfully according to your plan. This documentation provides evidence of controlled deployment and supports post-market surveillance activities.
Risk Management Integration
Your deployment evaluation must integrate with your overall risk management process. Consider deployment-specific risks such as network security vulnerabilities, infrastructure failures, user training gaps, and environmental factors. Implement appropriate risk controls and monitor their effectiveness throughout the deployment lifecycle.
Change Control and Version Management
Establish procedures for managing software updates and configuration changes in deployed environments. Document the deployed software version, track any customizations or configurations, and maintain change control procedures for future updates. This ensures traceability and supports regulatory compliance for software modifications.
Example
Scenario
You are deploying a cloud-based diagnostic imaging software to a large hospital network. The hospital has multiple departments, complex IT infrastructure with various imaging systems, and strict cybersecurity requirements. The software processes medical images from different modalities and provides AI-assisted diagnostic recommendations to radiologists.
Example Deployment Evaluation
Customer Information
| Customer Information | Details |
|---|---|
| Customer Contact Name | Dr. Sarah Johnson, Chief Medical Officer |
| Customer Contact Email | s.johnson@cityhospital.com |
| Customer Contact Phone | +1-555-0123 |
| Customer Company Name | City General Hospital Network |
| Customer Company Address | 123 Medical Center Drive, Healthcare City, HC 12345 |
Infrastructure Assessment
Infrastructure Description: Large hospital network with 500+ beds, multiple imaging departments (radiology, cardiology, emergency), existing PACS system, hospital information system (HIS), and electronic health records (EHR). Network includes both wired and wireless connectivity with strict firewall policies and VPN access for remote users.
Infrastructure Complexity: The infrastructure is complex with multiple interdependencies and a medium to high risk of system failures or issues that could compromise the safety and performance of the deployed device.
Justification: The hospital environment has critical interdependencies between imaging systems, network infrastructure, and clinical workflows. Network failures could prevent access to diagnostic tools during emergency situations, potentially impacting patient care. The complex security requirements and integration with existing systems create multiple potential failure points.
Installation Plan
Installation Approach: Remote installation with on-site technical support during initial deployment.
Installation Steps:
- Pre-deployment network connectivity testing
- Software installation on hospital servers
- Integration testing with existing PACS system
- User account setup and authentication verification
- Clinical workflow testing with sample cases
- Staff training and go-live support
Acceptance Criteria:
- Radiologists can successfully log into the system
- Medical images load within 10 seconds from PACS integration
- AI diagnostic recommendations display correctly
- Audit logs capture all user activities
- System maintains 99.9% uptime during 48-hour monitoring period
Monitoring Plan
Monitoring Approach: Automatic monitoring with manual oversight.
Monitoring Description: Automated system monitoring through cloud-based telemetry collecting performance metrics, error logs, and usage statistics. Weekly check-in calls with IT department and monthly clinical feedback sessions with radiologists. Real-time alerts for system errors or performance degradation.