161 lines
7.0 KiB
Markdown
161 lines
7.0 KiB
Markdown
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# 1. General Information
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This SOP describes how we support the initial integration and update of integrations of our medical devices
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into the IT systems of our customers. Furthermore, it covers user management and user training. By following
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this process, we want to make sure that our customers receive our medical devices or services the intended
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way.
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> Obvious disclaimer!
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>
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> The deployment process should be very much customized to the context of your specific product. Are you
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> deploying your product web-based? Are you integrating with local healthcare providers' IT systems? Depending
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> on those questions, you will have to write each single process step of this template. Sorry to disappoint
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> you! Hope the structure helps you at least to get an idea of the regulatory requirements.
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**Regulatory references:**
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* ISO 13485:2016 Chapter 7.5
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**Relevant other documentation:**
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* Integration Evaluation Checklist (IECL)
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* Integration Validation Checklist (IVCL)
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* Software Requirement Specifications
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* List of Medical Devices (PROD)
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* User Training Strategy
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* Template User Training Record
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* User Consent Form (if applicable)
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## 1.1. Integration Specifications
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Integration Specifications are the technical requirements defined in the instructions for use as part of the
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technical documentation of medical devices.
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## 1.2. Integration Checklists
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The Integration Specifications are used to compile the Integration Evaluation Checklist. It is ensured that we
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do not offer medical devices or services which cannot be delivered by filling out this checklist, for which
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the Operations Team Representative is responsible. We fill out the Integration Validation Checklist after
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concluding integration work in order to validate if all technical requirements for successful integration have
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been completed.
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## 1.3. Device Traceability
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The operations team ensures that only released device versions are deployed to the customer
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environment. Deployment of device versions is documented as part of the medical device list. This file must
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contain at minimum:
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* Use description (e.g. clinical use, test, etc.)
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* Device description (e.g. device version, UDI, release date, identification number of the NB acc. to CE
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certificate)
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* Company and contact data to a responsible person, deployment location
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## 1.4. Project Management Tool
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Optional:
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\<enter name\> is used as the project management tool to coordinate integration work.
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# 2. Process Overview
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## 2.1. Evaluation of Integration Requirements per Customer
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> Possible contents of this process step:
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>
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> * Following the draft of an offer / contract with a customer, the sales team reaches out to the technical
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> operations team to evaluate if technical requirements are met.
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> * In coordination with competent staff on the customer’s side, the technical operations team gathers
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> relevant information to fill out the integration evaluation checklist.
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> * If evaluation output does not allow for integration, the Operations team assesses other integration
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> possibilities or recommends to not further pursue the customer contract.
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> * The operations team communicates the result of the evaluation to the sales team.
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(...)
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## 2.2. Integration Coordination
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> Possible contents of this process step:
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>
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> * Following integration evaluation and the conclusion of a new customer contract, the operations team is
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> responsible to coordinate overall integration efforts.
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> * The operations team communicates to the customer (technical department) appropriate technical information
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> and guidance for the integration.
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> * If integration problems occur, the operations team is responsible to (a) amend the integration evaluation
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> checklist in order to prevent similar problems with future customers. (b) initiate the change management
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> process in case the medical device itself needs to be changed.
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> * Successful integration is validated by filling out the integration validation checklist. The operations
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> team obtains written confirmation of the customer setup after integration.
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> * The operations team informs the sales team once integration is complete. It documents the deployment date,
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> deployed version of the device and customer information as part of the medical device list.
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(...)
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## 2.3. Algorithm Deployment and Configuration
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> Optional for ML-driven devices: after integration and before go-live, test the algorithm on
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> customer-specific live data (e.g. in the form of a “shadow mode” where algorithm results are not used in the
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> clinical setting yet). Evaluate the results together with users.
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(...)
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## 2.4. User Administration
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> Possible contents of this process step:
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>
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> * The operations team is responsible to activate users accounts according to the customer contract.
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> * No user account is activated without / before
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> * Specification in the customer contract (e.g. number of seats?)
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> * Full completion of previous process steps (e.g. algorithm test)
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> * Optional to add here: user consent according to GDPR?
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(...)
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## 2.5. User Training
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> Possible contents of this process step:
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>
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> * The operations team is responsible to provide users with the instructions for use / user manual. If not
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> part of the device, provision via email is sufficient.
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> * The operations team conducts user training as defined in the user training strategy and documents every
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> training in the template for user training records.
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> * The operations team informs the sales and regulatory team about successfully completed training.
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(...)
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## 2.6. Handling of Feedback
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In case the operations team receives feedback (questions, complaints, praise, etc.) regarding the
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organization’s medical devices and services, it proceeds as outlined in the SOP feedback management.
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## 2.7. Handling of Updates
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> Possible contents of this process step:
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>
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> * In case of a version update, the operations team verifies if the integration requirements change due to
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> the update and, if necessary, implements changes accordingly.
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> * The operations team coordinates updates with the customer prior to deployment and, if applicable, notifies
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> the customer of potential product downtime according to the timeframe stated in customer contracts.
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> * After deployment, the latest deployed version is documented in the medical device list.
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(...)
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## 2.8. Handling of Terminated Contracts
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> Possible contents of this process step:
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>
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> * The sales team notifies the operations team in case of a terminated contract. Thereafter, the operations
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> team is responsible for deactivating respective user accounts.
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> * The medical device list is updated accordingly.
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> * If required, the operations team is responsible to support the customer with necessary data migration and
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> archives data related to the respective customer according to GDPR requirements (reference privacy policy
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> or similar here).
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(...)
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---
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Template Copyright [openregulatory.com](https://openregulatory.com). See [template
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license](https://openregulatory.com/template-license).
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Please don't remove this notice even if you've modified contents of this template.
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