In a message dated 98-08-13 16:32:29 EDT, Becky001 writes:
<< emc-p...@majordomo.ieee.org >>
--- Begin Message ---
I am working on a machine that has electrodes that are attached to the skin to
measure various electrical signals. This machine is battery powered. My
question is : am I required to conform to any FDA design rules in this area ?
When the machine goes into production, do I have to find a manufacturer that
is specifically qualified to produce medical device ? Is a ISO9000
certification sufficient qualification for a manufacturer to produce this item
?
Rebeca Chan
--- End Message ---
