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This document describes the processes for production and service provisions including builds, deployment, installation, integration, and update of integrations of medical devices produced by the manufacturer into required systems for access and use.
All medical devices that require a build and/or production environment, deployment, and/or integration into a system in order to function according to its intended use.
Production and service provision are planned, carried out, monitored and controlled to ensure that the product conforms to the specification. The scope of the process required for installation, integration, monitoring and control are dependent on the complexity of the system in which the product will be deployed, with more complex systems requiring more oversight due to increased potential for products not conforming to their specifications.
Production controls shall include the following but are not limited to the following (based on system complexity):
The following sections outline the procedures for infrastructure qualification, installation, integration, monitoring and control of deployed medical devices.
Infrastructure for deployment of medical device shall be determined during the development of the medical device according to the SOP Software Development. Infrastructure that is well-defined and controlled does not require installation qualification and can be considered as part of the software system test procedures as environmental testing of the software can be achieved through the software system test procedures.
Infrastructure that is not well-defined and controlled shall require installation qualification to ensure that the infrastructure is capable of supporting the medical device. Infrastructure qualification is part of the Deployment Evaluation Checklist and shall be completed prior to deployment of the medical device.
To determine whether infrastructure qualification is required, the Deployment Evaluation Checklist shall be completed. If the checklist indicates that infrastructure qualification is not required, no further assessment is needed. If the checklist indicates that infrastructure qualification is required, the checklist shall be completed and an installation plan shall be created (see section 6.1).
The specific qualification requirements for different types of infrastructure (web services, desktop/laptop applications, and mobile applications) shall be documented in the deployment evaluation checklist. These shall specify the necessary steps to ensure that the infrastructure is capable of supporting the medical device.
The software build process itself is defined and controlled according to the SOP Software Development. For deployment purposes, only validated and approved builds shall be used. The following requirements apply to builds intended for deployment:
The transition from development to deployment shall be formally controlled with appropriate approvals as defined in the SOP Software Development. This ensures that only properly built, tested, and approved software is deployed to production environments.
For any deployment onto qualified infrastructure, the Deployment Evaluation Checklist will need to be completed. This checklist will outline the installation plan, the monitoring and process measurements requirements, packaging and labeling requirements (as needed), and product release and delivery activities.
Installation cannot occur until a sales contract has been signed between the organization and the purchasing entity requiring installation. The business team ensures that only released device versions are deployed to the customer environment. Deployment of device versions is documented as part of the List of Medical Devices.
Should an infrastructure require installation procedures and qualification, a plan for the installation should be created using the Deployment Evaluation Checklist. Members of the business team should be available to assist with the installation process, as needed.
The installation plan should be established prior to providing installation on site or remotely. Predefined test criteria for ensuring that the installation has occurred successfully should be established and documented in the Deployment Evaluation Checklist.
Should the installation qualification fail and the predefined test criteria are not met for the software, repairs can be made to attempt to meet the predefined test criteria. If the predefined test criteria are not met after repairs, the installation should be considered a failure and the installation should be stopped.
Equipment or processes for the monitoring and measurement of the medical device should be established and correspond to the requirements of the medical device and the complexity of the infrastructure in which the medical device is deployed. More stringent monitoring and measurement activities should be established for more complex systems with a greater likelihood for impacting the performance and safety of the medical device.
In lieu of automatic monitoring or measuring equipment, manual reporting of device performance can be established. This can include regular check ins with the customer from the business team to ensure that the device is performing as expected and without significant errors. Customer support and lines of communication should be established in order to ensure that the customer can report any issues with the device.
If user training is required in order to operate the deployed device successfully, it should be provided upon installation or at some point prior to the first use of the deployed medical device on the customer's infrastructure. User training should follow what is required in the Instructions for Use.
In case of a version update to a deployed device, the business team will verify whether the update requires additional integration or installation steps in order to perform as intended. If so, the business team will coordinate with the customer to ensure that the update is performed successfully through remote deployment or with an on-site installation team to assist in successful deployment. If applicable, the customer should be notified of the potential impact of any downtime that may occur during the update process.
When a deployed device is required to be removed from a system due to the ending of a customer contract or other circumstances that require its removal, the business team should coordinate the uninstallation of the deployed device from the relevant systems. The business team should coordinate an on-site or remote visit with the customer to ensure that the device is removed successfully and that the customer is satisfied with the removal process. Finally, the business team should verify that the product was successfully removed, that the device is no longer operational on the customer end, and that the necessary data migration, storage and archiving has occurred according to customer preferences and General Data and Protection Regulation (GDPR) requirements.
