Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability?

#1
What is the certification procedure for OEM/PLM collaboration in the medical device industry in the US? Who must bear the regulatory responsability?
 
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#2
Usually the PLM would bear that responsibility, but to make a determination in a specific case access to the actual details is required. Namely, who they are, what each does and what's in the labeling.
 
#3
What are the regulatory responsibilities of an OEM and a Private Label manufacturer within the medical device industry in Canada? Can the PLM refer to the technical file of the OEM? How common is this business model in this country?
 
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#4
What are the regulatory responsibilities of an OEM and a Private Label manufacturer within the medical device industry in Japan? Can the PLM refer to the technical file of the OEM? How common is this business model in Japan?
 
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#5
What are the regulatory responsibilities of an OEM and a Private Label manufacturer within the medical device industry in China? Can the PLM refer to the technical file of the OEM? How common is this business model in China?
 
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#6
What are the regulatory responsibilities of an OEM and a Private Label manufacturer in the US? Can the PLM refer to the technical file of the OEM?
 
#7
What are the regulatory responsibilities of an OEM and a Private label manufacturer within the medical device industry in Australia? Can the PLM refer to the technical file of the OEM? How common is this business model in Australia?
 
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#8
What are the regulatory responsibilities of an OEM and a Private label manufacturer within the medical device industry in South Africa? Can the PLM refer to the technical file of the OEM? How common is this business model in the aforementioned country?
 
#9
What are the regulatory responsibilities of an OEM and a Private Label manufacturer withing the medical device industry in the US? Can the PLM refer to the technical file of the OEM? How common is this business practice in this country?
 
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