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.