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Posted On: 05/28/2021 2:57:37 PM
Post# of 9142
FYI: In a rough nut shell. If you can pass "one" of the countries validations for your device, you will pass all.
https://www.fda.gov/medical-devices/cdrh-inte...gram-mdsap
https://www.fda.gov/medical-devices/cdrh-inte...gram-mdsap
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