1. General Overview
This SOP outlines the process for supporting the initial integration and updates of our medical devices into customers’ IT systems. It also includes user management and training. The purpose of following this procedure is to ensure our medical devices or services are delivered as intended.
Important Note:
The deployment process should be tailored to the specific context of your product. Whether the deployment is web-based or involves integration with local healthcare IT systems, each step in this template must be customized. We hope the structure serves as a helpful guide for understanding the relevant regulatory requirements.
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Regulatory References:
- ISO 13485:2016 Chapter 7.5
Related Documentation:
- Integration Evaluation Checklist (IECL)
- Integration Validation Checklist (IVCL)
- Software Requirement Specifications
- List of Medical Devices (PROD)
- User Training Strategy
- Template User Training Record
- User Consent Form (if applicable)
1.1. Integration Requirements
Integration Requirements are the technical specifications outlined in the instructions for use, forming part of the medical device’s technical documentation.
1.2. Integration Checklists
Integration Requirements are used to create the Integration Evaluation Checklist, ensuring that medical devices or services are only offered if they meet these requirements. The Operations Team Representative is accountable for completing this checklist. Following integration work, the Integration Validation Checklist is filled out to confirm that all technical integration requirements have been met.
1.3. Device Traceability
The operations team ensures that only approved versions of the device are deployed in customer environments. Deployment records are maintained as part of the medical device list, which must include:
- Usage description (e.g., clinical, testing, etc.)
- Device details (e.g., version, UDI, release date, NB identification per CE certificate)
- Contact information of the responsible person and deployment location
1.4. Project Management Tool
Optional:
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2. Process Overview
2.1. Customer Integration Requirements Evaluation
Potential elements of this step:
- Following an offer or contract draft with a customer, the sales team consults with the technical operations team to assess if the integration requirements are met.
- The technical operations team collaborates with relevant personnel from the customer side to gather necessary data and complete the integration evaluation checklist.
- If the evaluation reveals that integration is not feasible, the Operations team will explore alternative options or advise against pursuing the customer contract.
- The operations team communicates the evaluation results to the sales team.
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2.2. Coordination of Integration
Potential elements of this step:
- Following integration evaluation and contract finalization, the operations team oversees coordination of the integration.
- The operations team shares relevant technical details and instructions with the customer’s technical team.
- In the event of integration issues, the operations team (a) updates the integration evaluation checklist to prevent future occurrences and (b) initiates a change management process if modifications to the device are needed.
- Integration success is confirmed through the completion of the integration validation checklist. The operations team secures written confirmation from the customer after integration.
- The sales team is notified when integration is complete. Deployment date, device version, and customer details are documented in the medical device list.
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2.3. Deployment and Configuration of Algorithms
Optional for machine learning-based devices: Before going live, test the algorithm on live data specific to the customer (e.g., using “shadow mode” where the algorithm’s results are not yet used in clinical settings). Evaluate results in collaboration with users.
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2.4. User Account Management
Potential elements of this step:
- The operations team activates user accounts according to customer contract specifications.
- User accounts are not activated without:
- Specification in the customer contract (e.g., seat count)
- Completion of prerequisite process steps (e.g., algorithm testing)
- Optional: User consent per GDPR compliance
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2.5. User Training
Potential elements of this step:
- The operations team ensures users receive the instructions for use or user manual. If not included with the device, this can be sent via email.
- User training is conducted as outlined in the user training strategy, with each session documented using the user training record template.
- The operations team informs the sales and regulatory teams after completing user training.
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2.6. Feedback Management
When the operations team receives feedback (questions, complaints, compliments, etc.) regarding medical devices or services, it follows the procedures outlined in the SOP for feedback management.
2.7. Update Management
Potential elements of this step:
- For version updates, the operations team checks if integration requirements are impacted by the update and implements necessary changes.
- The operations team coordinates with the customer for updates prior to deployment and notifies the customer of potential downtimes as stated in the contract.
- After deployment, the most recent version is recorded in the medical device list.
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2.8. Contract Termination Handling
Potential elements of this step:
- When a contract is terminated, the sales team informs the operations team, which then deactivates user accounts.
- The medical device list is updated as needed.
- If necessary, the operations team assists with data migration and stores data related to the customer in accordance with GDPR requirements (refer to the privacy policy or similar documents).
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