Overview

Supports the Premarket submission of a medical device. Using a data model based on Teamcenter to allow for easy future integration, the application uses workflow to implement the necessary approval steps and gather the appropriate data required before submittal to the regulator. Once submitted the device can be approved or rejected and the data stored to be transferred to Teamcenter, or further information can be requested, continuing the workflow.

Documentation

Premarket

Supports the Premarket submission of a medical device. Using a data model based on Teamcenter to allow for easy future integration, the application uses workflow to implement the necessary approval steps and gather the appropriate data required before submittal to the regulator.

Once submitted the device can be approved or rejected and the data stored to be transferred to Teamcenter, or further information can be requested, continuing the workflow.

How to setup

The application contains all of the data required on start up. The master data can be reset by signing in as an Administrator and navigating to Mock Data and selecting 'Reset Mock Data'.

The application can be requested, downloaded and can then be customised using Studio or Studio Pro to suit your needs.

User roles

Administrator - Responsible for the administration of the platform, including technical configuration and data management.

User - General user role for the different account disciplines (see below)

Anonymous - For anonymous access to the application.

Module Descriptions

Custom Admin Module - for administration and custom layouts

Submissions Module - manages the submissions workflow process

Mock Data - enables creation of sample data for demonstration purposes

Account Disciplines
Users are linked to account disciplines. These are hard coded into the workflow to route the submissions.

- Product Manager - Responsible for drafting submissions and the individuals ultimately responsible for gathering the required data.

- Quality Manager - Responsible for the QA review of the submission.

- Regulatory Manager - Responsible for the Regulatory review and submission to the Regulator.

- Regulatory Comms. - Responsible for communicating with the regulator and recording their response.

Data Model Description

The Submissions Module contains all of the information for management of the submissions process: 

- PLM Product Submission - To contain product data and connect to the Submittal Process.

- UDI Product Submission - Designed to be synchronised from Teamcenter, contains the product information.

- Submittal Process - Manages the submittal process. Multiple submittal process can be added for each Product Submission (e.g. for different regions)

- Submittal Info - For all submittal attachments.

- Region - The Region that the Submittal Process is connected to.

- Regulatory Type - The available Regulatory types. Note there is no direct association, the attribute on Submittal Process - Regulatory Type.

Process Description

The application has been designed to leverage mock data and user switcher has been provided for ease of demonstration.

Data creation

Information can be generated or reset by the administrator by clicking Configurations; Reset All MockData . This will read the JSON files located in the resources/mockdata folder and create corresponding data within the application. It will also create demonstration workflows at different stages.

Submissions Process

A new Submission can be created by signing in as the Product Manager and using the New button on the Product Submittal page. Following the wizard, the user can then add all of the required information. Once submitted the Submission Workflow will be initiated. The approval stages for the workflow are as follows: Quality Manager, Regulatory Manager and finally Regulatory Comms.

Rejection returns the workflow to the previous step, except at Regulatory Comms where Rejection closes the workflow, but marks it as Rejected.

Regulatory Comms can also 'Request More Information' which returns the process to the Product Manager, to restart the request from the wizard.

If everything is as expected when it reaches Regulatory Comms, the Submittal can be 'Accepted', which will allow for synchronisation with Teamcenter (pending).