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
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