Premarket Modules

Learn how to setup and implement the premarket modules: Design Control, Risk Management and Design History File.

Premarket Modules

Lesson 1: Welcome

About this course

Now that you have established your fundamental QMS which includes Document Control and Training Modules, you can begin documenting your premarket activities in Enzyme.

This includes:

  • Setting up Design Controls
  • Establishing Risk Management
  • Setting up your Design History File (DHF)

We'll provide step by step guidance and examples of best practices.

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Lessons in this course

Welcome
Design Control Module
Design Control Cards
Design Outputs
Managing Tracing Dependencies
Managing Design Control Cards
Design History File
Risk Management
Conclusion

Welcome

Now that you have established your fundamental QMS which includes Document Control and Training Modules, you can begin documenting your premarket activities 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

Let's get started!

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Course instructors

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This course

Other courses

Resources

Enzyme Certifications
Slack Community
Enzyme Blog
Job Board
Enzyme Community content is updated continually to provide you the best product. If screenshots or videos are out of date or you get stuck, please contact us.
Ready to level up? Inquire about certification.
info@enzyme.com or

Ready to do more?

Enzyme Members Only

This content is reserved for Enzyme QMS users.

Premarket Modules

Lesson 1: Welcome

Welcome

Now that you have established your fundamental QMS which includes Document Control and Training Modules, you can begin documenting your premarket activities 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

Let's get started!

Course instructors

This course

Other courses

Resources

Enzyme Certifications
Slack Community
Enzyme Blog
Support Center Articles
Job Board
Enzyme Community content is updated continually to provide you the best product. If screenshots or videos are out of date or you get stuck, please contact us.
Ready to level up? Inquire about certification.
info@enzyme.com or

Ready to do more?