• Fubin Wu

7 early steps for a safe and effective medical product

Updated: Nov 19

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. Write down the conceptual story about the device (why and what)

2. Summarize the intended use and intended benefits of the device

3. Create the device mission statement

4. Identify the mission essential functions and performance

5. Identify the primary hazards and security assets

6. Identify foreseeable hazardous scenarios and potential harms

7. Identify primary risk control 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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