Is cardiac waveform generator a medical device?

G

GGReg

#1
Sales staff wanted to demo ECGs without wasting electrodes. So the engineers whipped them up some simple analog-to-digital waveform generators that provide a simulated heartbeat, and now the ECG's UI and various functions can be displayed live.

These generators are NOT used for ECG testing or calibration. They are NOT sold to customers. They are not used in the presence of a patient. They are used solely by company employees during their sales pitches to medical professionals.

Are these generators covered under any part of 21 CFR 820 or ISO 13485?

Are we required to document their design history?

Do we need to validate them and document the validation activities?

I think all answers are NO, but am I missing anything?
 
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somashekar

Staff member
Super Moderator
#2
Sales staff wanted to demo ECGs without wasting electrodes. So the engineers whipped them up some simple analog-to-digital waveform generators that provide a simulated heartbeat, and now the ECG's UI and various functions can be displayed live.

These generators are NOT used for ECG testing or calibration. They are NOT sold to customers. They are not used in the presence of a patient. They are used solely by company employees during their sales pitches to medical professionals.

Are these generators covered under any part of 21 CFR 820 or ISO 13485?

Are we required to document their design history?

Do we need to validate them and document the validation activities?

I think all answers are NO, but am I missing anything?
Within the definition of medical device seen HERE your item is not a medical device .....
 
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