Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)?

S

snoopy2017

#1
#1
Hi,

If a company has an overseas manufacturer who receives all the DMR specifications from the parent company, who keeps the DMR? During an audit of the legal manufacturer, shouldn't the legal manufacturer have access to the DMR records? Thank you. How does the logistics work?
 
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Ed Panek

Ed Panek

QA RA Small Med Dev Company
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#2
#2
We have a contract manufacturer but we own the DHF, DMR and DHRs since we designed them and are the company of record. There may also be trade secrets involved so be careful.
 
William55401

William55401

Quite Involved in Discussions
#3
#3
Logistics? You decide with your contract manufacturing partner. A Quality Agreement is a good place to define who owns what as well as responsiveness expectations during a regulated audit.
 
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