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tamaranim1 [39]
3 years ago
15

A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker wil

l pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?
a. Significant risk device
b. non-significant risk device
Business
1 answer:
Anestetic [448]3 years ago
5 0

Answer:

A Significant risk device

Explanation:

A Significant risk device- it is referred to as a device that major function is to support human life. This includes all such devices used to diagnose, cure, treating disease to human health. An example of a significant device is a pacemaker, shunts used in heart, etc.

while on the other side nonsignificant devices include device like, eyes lens, its solution, dental scalers, etc

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