Overview
The Regulatory Roadmap provides a visual overview of all the key steps involved in bringing your medical device to market while complying with regulations. It’s organized into stages, starting from Quality Management System (QMS) setup and planning, through design, development, verification, validation, regulatory preparation, submission, and finally post-market activities.
Cards
The Regulatory Roadmap is made up of cards. Each card includes specific tasks, processes, or set of documents you need to complete. Think of it as a checklist for your regulatory journey.
As you work through the requirements and complete the documentation associated with each card, the card will turn green. This gives you a clear, at-a-glance view of your progress towards regulatory compliance and market readiness.
How to use the Roadmap
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Open the Regulatory Roadmap: Click on the “Roadmap” icon in the left sidebar.
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Navigate through the stages: Stages include QMS, Planning, Design and Development, Verification and Validation, Regulatory Preparation, Submission, and Post-Market. You will complete these from left to right and top to bottom.
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Using the cards: Click on a card to open the card modal. This will list all of the tasks associated with the card and the processes you need to complete. Once all the processes in the card are complete, then you can move on to the next card in the stage.
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Complete the tasks: Each card lists the tasks that need to be completed. Clicking on a task will take you to the document assistant or, if the document does not require any user input, to the fully generated document itself.
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Send documents for approval: Once the document is generated, you can send it for approval by clicking the “Approval” button on the top right of the document viewer. Learn more about the approval process in the document approval section.
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Complete the stage: Once all the tasks in the card are complete and the documents are approved, the card will turn green. This will indicate that the requirements covered by the card are now covered and you can move on to the next card in the stage.
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Complete the roadmap: Once all the cards in the stage are complete, the stage will turn green. This will indicate that the stage is now complete and you can move on to the next stage.
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Repeat: Repeat the process until you have completed all the stages in the roadmap up to the Submission stage. This will complete the roadmap for initial certification and you will be able to submit your device to the regulatory authority.