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ISO 13485 & Change of Address/Location
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ISO 13485 & Change of Address/Location
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addresses, california, ce mark and ce marking, iso 13485 - medical device qms
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  Post Number #1  
Old 30th April 2012, 04:15 PM
B Gridack

 
 
Total Posts: 2
Please Help! ISO 13485 & Change of Address/Location

Hello All:

My name is Paige Gridack and I am Document Control for a medical device company located in southern California. We may be changing physical locations soon. We are currently ISO 13485 certified & some of our products are CE marked.

From what I can glean from other threads, I will need to change our address with our Notified Body and on our certificate.

However I am looking for information on the following:

1. 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.

2. What, besides contacting our Notified Body & changing the Certificate, do I need to do to update our CE Certification?

3. 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?

4. Finally, what are the California state regulations regarding a change of address? This is probably the most difficult.

I am in the process of researching all of these answers independently, but the collective intelligence would be greatly appreciated.

Thank you!

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  Post Number #2  
Old 30th April 2012, 09:30 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,362
Re: ISO 13485 & Change of Address

Hi Paige, ... Welcome to the Cove ~~~
Quote:
1. 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.
Contact your CB well in advance and with a date plan of probable effective change. The location as in your ISO13485 certificate concerns to the scope and processes that you perform at that location. Any change in location will have to be re-assessed for the effective performing of the stated scope. This may lead to a separate audit with a scope change of "Change in location" or can be merged with your annual assessment depending upon time plan and prior communication with your CB.
Quote:
2. What, besides contacting our Notified Body & changing the Certificate, do I need to do to update our CE Certification?
The CE certificate is the property of the NB. Any change in the scope stated in the CE certificate will render the CE certificate invalid. Please contact the NB well in advance again with a date plan of probable effective change. You will also address how your label change control is effected, and keep records of the last batch / Sl number of the medical devices labelled with your current location on them. To effect change in your CE certificate, the NB will also perform a MDD assessment at the new location for the scope claimed. If your CB and NB are the same., then this and the 1. above can be planned into one visit by them to the new location. A good planning and dialogue with your NB can ensure that your CE certificate does not have a break in validity. Most of the activities that you do for the 1. above will be effective for this as well.
  Post Number #3  
Old 1st May 2012, 03:04 AM
harry

 
 
Total Posts: 6,290
Re: ISO 13485 & Change of Address/Location

Quote:
In Reply to Parent Post by B Gridack View Post

............................ 4. Finally, what are the California state regulations regarding a change of address? This is probably the most difficult. ...............................
I am not from California but generally, this part pertains to business registration which is similar in most parts of the world.

All legitimate business organizations need to be registered with the authorities. Over here, it is the Registrar of Companies and we do it through regulated or registered organizations called 'Company Secretaries'. Just get your company secretary to file a change of address with the relevant authority - no hassles.
  Post Number #4  
Old 2nd May 2012, 01:56 AM
Ronen E

 
 
Total Posts: 3,736
Re: ISO 13485 & Change of Address/Location

Quote:
In Reply to Parent Post by B Gridack View Post

Hello All:

My name is Paige Gridack and I am Document Control for a medical device company located in southern California. We may be changing physical locations soon. We are currently ISO 13485 certified & some of our products are CE marked.

From what I can glean from other threads, I will need to change our address with our Notified Body and on our certificate.

However I am looking for information on the following:

1. 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.

2. What, besides contacting our Notified Body & changing the Certificate, do I need to do to update our CE Certification?

3. 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?

4. Finally, what are the California state regulations regarding a change of address? This is probably the most difficult.

I am in the process of researching all of these answers independently, but the collective intelligence would be greatly appreciated.

Thank you!
Hello Paige and welcome to the cove

I'm not sure what you mean by "I am Document Control"... I know some organisations have defined positions for document control officers etc. - 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 would expect such responsibility to more naturally rest with a rather-senior quality management / regulatory affairs role holder.

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. your company) address on all device labeling.

I recommend you try and summon a team of colleagues, knowledgable in the relevant fields, and together try to first identify and list (hi-level) all the formal implications of moving your business to another location. Once such a list is compiled, you could drill-down on each and every item to identify the specific tasks and requirements, assign action responsibilities, due dates, review responsibilities etc. etc.

Consulting with your NB (which I assume is also your ISO 13485 registrar) is definitely a step forward.

ISO 13485 certificates bear the certified organisation address, regardless of the types of activities caried on on-site, so that's something to address. I also recommend a re-read of all applicable ISO 13485 sections, in conjunction with your QMS written procedures, to identify any areas / topics where location change may be an issue requiring action.

To identify applicable FDA requirements and expectations in view of the planned move, I'd go for a complete (not necessarily lengthy, I'd start hi-level) review of the controls applicable to the devices you make (General Controls and, as applicable, Special Controls and PMA - depnds on device class).

I'm not an expert on California state specific rules and regulations, but California is notorious for having stricter-than-usual rules in many fields... A preliminary web research would probably point you in the right directions; I wouldn't limit myself to business registration and medical devices specific state regulations - there may (or may not) be all sorts of repercussions. Sorry I can't be more specific about that.

Fare well
Ronen.
  Post Number #5  
Old 2nd May 2012, 08:57 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: ISO 13485 & Change of Address/Location

For FDA, have the person who manages the Registration of the company and Listing of its products at https://www.access.fda.gov/oaa/ (the FURLS/DLRM site) log into that site and change the address.

Also: probably this doesn't apply, but if your company is subject to a current post-FDA-inspection corrective action process or an ongoing recall process, you probably should call up your local region and inform them directly of the move. In the former case, if you have only a Form 483, it would provide your contact. If you were issued a Warning Letter, you'd use the contact provided on that document. In the latter case, you'd speak to the regional office's Recall Coordinator.

Last edited by MIREGMGR; 2nd May 2012 at 09:02 AM.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #6  
Old 2nd May 2012, 10:37 AM
jradford

 
 
Total Posts: 51
Re: ISO 13485 & Change of Address/Location

We are a small medical manufactuing company in NY. We recently moved up the road a few miles to a new location. To get new copies of our certs with the new address required a move risk plan, a visit by our notified body, samples of our labeling with the new address, and a $2500 fee. We moved in February and I just got the certificats last week, so it is not a quick process.

Ah, here is the actual text from the email:

During this visit, I would like you to present me the action plan relative to the move, including
- all necessary items relative to company registration and device license/listing;
- effect on the products and the demonstration of compliance to the essential requirements
- all necessary items relative to the demonstration of the continuation of the QMS during this transfer.
Thank You to jradford for your informative Post and/or Attachment!
  Post Number #7  
Old 2nd May 2012, 11:10 AM
B Gridack

 
 
Total Posts: 2
Re: ISO 13485 & Change of Address/Location

Hello All:

Thank you so much for you advice. As some have come to suspect, I am in training to bridge the gap between Document Control & Regulatory Affairs (both departments have one person, like I said, small company). Doing this research is part of my regulatory affairs training. I am compiling notes from the forum and using them to bolster my internet research.

Again, I appreciate all the advice presented.

Paige Gridack
  Post Number #8  
Old 2nd May 2012, 06:38 PM
Ronen E

 
 
Total Posts: 3,736
Re: ISO 13485 & Change of Address/Location

Quote:
In Reply to Parent Post by jradford View Post

We are a small medical manufactuing company in NY. We recently moved up the road a few miles to a new location. To get new copies of our certs with the new address required a move risk plan, a visit by our notified body, samples of our labeling with the new address, and a $2500 fee. We moved in February and I just got the certificats last week, so it is not a quick process.

Ah, here is the actual text from the email:

During this visit, I would like you to present me the action plan relative to the move, including
- all necessary items relative to company registration and device license/listing;
- effect on the products and the demonstration of compliance to the essential requirements
- all necessary items relative to the demonstration of the continuation of the QMS during this transfer.
Thanks for this first-hand info!

Sounds like it was coordinated well with your NB; could you please also say whether it was similarly coordinated with the FDA, NY state and/or local authorities?

I got a little confused by the quoted message, as it clearly relates to EC terminology ("essential requirements"), however, "company registration and device license/listing" sound more like FDA terminology.

Cheers,
Ronen.
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