ISO 13485 - EU countries that could request another audit

#1
Hello,

I am looking for the countries that despite the presence of an ISO 13485 certificate, "another" audit could be requested. I have heard about Ukraine.
could someone help me?

thank you
regards
 
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Sidney Vianna

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#2
I have not heard anything along those lines, but is a well known fact that some Medical Device Authorities around the World have concerns over the "pedigree"/credibility of some ISO 13485 certificates issued by less than serious actors.

I also know that some of the people behind the IAF Certsearch database come from the Medical Device Arena and they were pushing for a way to promptly monitor the validity and provenance of ISO 13485 certificates. Unfortunately, for them, the unregulated accredited certification process has been commoditized to a point where low cost Accreditation Bodies have been allowed under the IAF umbrella and ultra-low cost certification bodies can now issue certificates to a plethora of standards, all under the IAF MLA and recognition....one certificate....recognized everywhere.....through robust and rigorous audits :sarcasm:
 
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