supplier gives us the kit as "ready to fill" state; and in the kit, he does
1. fabricate a major component;
2. sterilizes 2-other components
3. has a component which is pre-sterilized
so the question is,
a. can he take "exclusion" criteria for "design and development" for ISO 13485 section and
b. what is the need to register himself as an 'device' manufacturer with FDA 820.
my assessment is that,
a. he should not take exclusion from ISO "design and development"
b. being 'kit' - with adding value to components, to make it "ready to fill", supplier, my assessment is that he should register himself as an device supplier with FDA
pl. give reference and guide
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