OpenRegulatory Template

1. General Information

This SOP describes how we support the initial integration and update of integrations of our medical devices into the IT systems of our customers. Furthermore, it covers user management and user training. By following this process, we want to make sure that our customers receive our medical devices or services the intended way.

Obvious disclaimer!

The deployment process should be very much customized to the context of your specific product. Are you deploying your product web-based? Are you integrating with local healthcare providers’ IT systems? Depending on those questions, you will have to write each single process step of this template. Sorry to disappoint you! Hope the structure helps you at least to get an idea of the regulatory requirements.

Regulatory references:

Relevant other documentation:

1.1. Integration Specifications

Integration Specifications are the technical requirements defined in the instructions for use as part of the technical documentation of medical devices.

1.2. Integration Checklists

The Integration Specifications are used to compile the Integration Evaluation Checklist. It is ensured that we do not offer medical devices or services which cannot be delivered by filling out this checklist, for which the Operations Team Representative is responsible. We fill out the Integration Validation Checklist after concluding integration work in order to validate if all technical requirements for successful integration have been completed.

1.3. Device Traceability

The operations team ensures that only released device versions are deployed to the customer environment. Deployment of device versions is documented as part of the medical device list. This file must contain at minimum:

1.4. Project Management Tool

Optional:

<enter name> is used as the project management tool to coordinate integration work.

2. Process Overview

2.1. Evaluation of Integration Requirements per Customer

Possible contents of this process step:

(…)

2.2. Integration Coordination

Possible contents of this process step:

(…)

2.3. Algorithm Deployment and Configuration

Optional for ML-driven devices: after integration and before go-live, test the algorithm on customer-specific live data (e.g. in the form of a “shadow mode” where algorithm results are not used in the clinical setting yet). Evaluate the results together with users.

(…)

2.4. User Administration

Possible contents of this process step:

(…)

2.5. User Training

Possible contents of this process step:

(…)

2.6. Handling of Feedback

In case the operations team receives feedback (questions, complaints, praise, etc.) regarding the organization’s medical devices and services, it proceeds as outlined in the SOP feedback management.

2.7. Handling of Updates

Possible contents of this process step:

(…)

2.8. Handling of Terminated Contracts

Possible contents of this process step:

(…)


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Please don’t remove this notice even if you’ve modified contents of this template.