AAMI EC57 for ECG Medical Device - Seeking 3rd Party Test Laboratory

S

szszsz

#1
#1
Hi,
We are trying to get 510(k) clearance for our patient monitor. FDA reviewer asked us to provide AAMI EC57 report on heart-rate measurement module.

Does anyone know a 3rd-party who provides this type of test service?

Thank you.

Jimmy
 
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Y

yousun

#3
#3
Jimmy,

have you found a test lab now? how is your test going? would you like to share some information. I think I am going to need same service in the feature.

Best Regards,

David
 
Y

yousun

#5
#5
thank you for your fast response, It may be a good business to start a test lab for ECG AAMI qualifying.
have a nice day.
 
A

Alireza_52

#6
#6
Jimmy and David,

Not sure if you are over this issue but I can provide consulting to do the tests according to EC57 and prepare the test results at Biomedian LLC.

Ali
 
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