Dear Friends,

I have two questions can anybody answer -

1. Does USFDA approval of Invitro Diagnostic Devices (Automated Biochemistry analyser (photometer) )requires safety approvals
e.g. complaince to IEC61010-1 or UL product safty certification is necessary.
2. USFDA 21CFR part11 talks about requirements for electronic record. Is it mandetory to keep records in electronic form or can
we maintain records in harcopy form. If the records are to be maintained in hardcopy how to maintain records for embedded
software/application software(LIMS).

Regards,
Vijay Chavan
e-mail: v.chavan@transasia.co.in

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