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ER Checklist - Method(s) of conformity
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ER Checklist - Method(s) of conformity
ER Checklist - Method(s) of conformity
ER Checklist - Method(s) of conformity
ER Checklist - Method(s) of conformity
ER Checklist - Method(s) of conformity
ER Checklist - Method(s) of conformity
ER Checklist - Method(s) of conformity
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  Post Number #1  
Old 12th January 2018, 05:26 PM
tebusse

 
 
Total Posts: 73
Please Help! ER Checklist - Method(s) of conformity

All,

I'm putting together my first essential requirement checklists for two Class I medical devices in preparation for CE Marking. One of these medical devices is electrical and we've had a 3rd party vendor conduct CB scheme testing.

For applicable ERs, I believe I can list the standard documented on the test certificates to which our device was found to be in conformity with - correct?

However, I'm noticing that the test certificates and the test reports do not have the same standards listed. Am I also able to list the standards from the test reports for applicable ERs?

Thank you, Tonia

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  Post Number #2  
Old 14th January 2018, 04:03 AM
shimonv

 
 
Total Posts: 246
Re: ER Checklist - Method(s) of conformity

Quote:
In Reply to Parent Post by tebusse View Post

For applicable ERs, I believe I can list the standard documented on the test certificates to which our device was found to be in conformity with - correct?
Yes.

Quote:
In Reply to Parent Post by tebusse View Post

However, I'm noticing that the test certificates and the test reports do not have the same standards listed. Am I also able to list the standards from the test reports for applicable ERs?
Usually one test report is issued per one tested standard. I recommend to list just one standard (e.g. IEC 60601-1) and in parallel send and inquiry to the test lab to sort out this seemingly discrepency.
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