your company) address on all device labeling.
#Iso 13485 updates iso
The plain fact is that there may be much more to the relocation than the change of establishment (physical) address on an EC or ISO 13485 certificate, the least of which NOT being changing the manufacturer (LEGAL manufacturer, i.e. I would expect such responsibility to more naturally rest with a rather-senior quality management / regulatory affairs role holder. these jobs usually involve chasing / overseeing internal processes involving initiation and/or creation and/or changing and/or review and/or approval of controlled documents - is this (roughly) your job description? If it is, or it's close enough, then I wonder why you are left responsible for researching and identifying the formal action items relating to the establishment relocation. I know some organisations have defined positions for document control officers etc. I'm not sure what you mean by "I am Document Control". I am in the process of researching all of these answers independently, but the collective intelligence would be greatly appreciated.Ĭlick to expand.Hello Paige and welcome to the cove Finally, what are the California state regulations regarding a change of address? This is probably the most difficult.
#Iso 13485 updates update
What are the USA federal requirements for a change of address? I understand we will have to update the address, but are there any possible inspections?Ĥ. What, besides contacting our Notified Body & changing the Certificate, do I need to do to update our CE Certification?ģ. Are there any change of location requirements for ISO 13485? My supervisor mentioned something about a possible inspection, but I believe that is only for manufacturing on site, which we do not do.Ģ. However I am looking for information on the following:ġ. We are currently ISO 13485 certified & some of our products are CE marked.įrom what I can glean from other threads, I will need to change our address with our Notified Body and on our certificate. We may be changing physical locations soon. My name is Paige Gridack and I am Document Control for a medical device company located in southern California.
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