Based on your role and permission level, you may be responsible for helping manage the premarket modules in Enzyme.

In your premarket activities, you should:

  • Document your product development activities

  • Document product risk and how it will be mitigated in your design

  • Manage your suppliers

Design Control Module

The Design Control Module documents the way in which your product meets user-defined needs, company-defined needs, and how the device fulfills its intended uses.

The FDA (and notified bodies) want to make sure that your company has a plan for the design process and is following it.

  • User Needs express the user's (physician, clinical staff, and patients) desires and needs for the product.

  • Requirements are the features of the product that will be implemented to meet the user needs.

  • Design Outputs are the products of your design process (drawings, specifications, software builds, etc.).

  • Verifications are the protocols used to test your product and confirm that the requirements are met. The reports also provide evidence that the requirements were satisfied.

  • Validations are the protocols and reports that demonstrate that your user needs are met and documented. This includes the clinical trials, human factors testing, etc. that are used to assess the product.

Here is an overview of the Design Control Module in Enzyme.

Design Control Cards

To start documenting your design, start by creating cards to outline your User Needs, Requirements, Design Outputs, Verifications, and Validations.

In Enzyme, users with the permission level of Quality Owner, Editor, and Approver can create Design Control cards. Viewers can only view Design Control cards.

Design Outputs

As you develop your product, you can start adding to Design Outputs.

Companies whose product includes software can link their production repository to a Design Output in Enzyme. This helps maintain change control and traceability. This can be accomplished by linking a Design Output card to a pull request using a protected branch pattern. This ensures that each code release to production cannot be merged until the Design Output card is approved through a change request in Enzyme.

Once a Design Output card is approved through a change request, any linking or unlinking of the pull request will pull that card back into Draft mode. The card will need to be resubmitted for approval. This is to ensure traceability and maintain a design history.

Managing Tracing Dependencies

Once you have added the new cards (including their tracing dependencies) , you can view all the design cards to which they are linked.

As you develop the product, this helps you verify that the Design Inputs are traced to your design outputs, verifications, and validations.

Managing Design Control Cards

When you create Design Control cards, they are in a draft state. To release them, add them to a Change Request and submit them for approval. We had discussed submitting change requests in the Document Control & Approvals course.

Once the Change Request is approved, cards can be edited or deleted. Any edits to an approved card returns it to the draft state and it must be resubmitted for approval.

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