B
Bridget
I am sure more than one of you has challenged the auditor to prevent a nonconformance? A nonconformance was written regarding the Medical Device Directive 92/42 EEC regarding clinical trials/investigations and I am trying to find the proof that substantiates this. We do not perform any clinical trials so the auditor wrote that “each technical file should state/reference the fact that no clinical trials are undertaken (Directive)” Can anyone point me to the section that states this must be documented in the Technical Files? By the way we have had these technical files since 1996 with no mention of this before.
Thanks,
Bridget
Thanks,
Bridget