Legalizing ISO 13485 certification with an US state department of health

tiptoe

Starting to get Involved
#1
Hi there,

Does anyone have experience getting an ISO 13485 Certificate legalized with their local US state department of health. I am currently working with Lebanon and they are requiring this. I was of the notion legalization was a 3 step process: notarization, county clerk's seal and Governor (state) seal. I contacted our state health department and couldn't get any answers. Please help if you have any experience with this. Thank you
 
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Ronen E

Problem Solver
Staff member
Moderator
#5
Before jumping through hoops, I would make sure that language barriers didn't blow this out of proportion. Are you fluent in Lebanese Arabic/French? Is your contact fluent in English? Maybe they intended something simpler?
Also, how well does your contact understand the essence, significance and process of ISO 13485 certification?
Personally, I've never heard of such a requirement / expectation (but maybe it's just my ignorance).
 
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