Dear members,
Is it okay to store the design files (device drawings) at contract manufacturer location if the scope of ISO13485 Certificate says scope as "Design,development,manufacturing,distribution and service of opticsl diagnostic systems for the area of ophthalmology"?
Appreciate,your valuable feedback.
Regards,
S.Rajesh
Is it okay to store the design files (device drawings) at contract manufacturer location if the scope of ISO13485 Certificate says scope as "Design,development,manufacturing,distribution and service of opticsl diagnostic systems for the area of ophthalmology"?
Appreciate,your valuable feedback.
Regards,
S.Rajesh