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  • Writer's pictureFubin Wu

7 predesign steps of highly effective design controls and risk management

Updated: Dec 8, 2022

Getting started on the right foot can save both time and money for developing a good medical product. Here is a list of steps that will be very helpful.

1. Conceptualize the device within the context of healthcare ecosystem

2. Clarify the intended use and intended outcome/benefits of the device

3. Create the device mission statement

4. Identify the mission essential functions and performance

5. Identify reasonably foreseeable hazardous scenarios and potential harms

6. Identify primary/essential safety and effectiveness measures

7. Identify proper performance requirement specifications for the primary/essential measures

As a proof of my belief in this, I have practiced these steps during our upcoming next generation software QMSpace development.

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