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Design and Development Exemption/NA confusion

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class ii medical device, design and development, exemptions, iso 13485:2016
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  Post Number #1  
Old 19th June 2018, 02:53 AM
kellylisa

 
 
Total Posts: 8
Please Help! Design and Development Exemption/NA confusion

hi All,

sorry if this is not in the right place and that I explain it adequately!

I've recently started work for a manufacturer of IIa devices in QA/RA and I am trying to update the QMS to address the newer revision of 13485 and the MDR.

we also distribute items for another company.

However, somehow (even though we are the manufacturer of 2 x devices and have always been responsible for the revision of the products - albeit they have employed external consultants to draw up new schematics etc) this company have managed to get through audits on their QMS and tech files as 'exempt' from the Design & Development elements of the Standard...not even so much as a Design History File anywhere to show what changes have been made over the years to the product (and I am unable, so far, to contact the CAD consultant to gain this information)

the products are DEFINITELY ours (not an OBL or anything) and the tech files have been given the 'ok' by the N.B, but I can't understand HOW on earth we can possible by exempt from the D&D elements of the Standard, given that the devices are our responsibility and WE decide how and when changes are made!? Our tech file has a very old revision of a drawing, which I don't even believe is the one currently being used by our Critical Supplier.

Am I missing something? I really want to contact the N.B, but i'm holding off so that I don't kick up too much dust prior to our audit (nobody likes to draw unwanted attention to themselves!)

i'm struggling to comprehend how this has been passed so many times by both auditors from the N.B as well as other Consultants that have been here before me (to be honest, it's making me feel stupid!!)

if there is anybody that can shed any light, i'd be very grateful.
I don't have anybody here that really understands what it is i'm talking to them about when I raise it - they just seem to think that because it's been ok and passed before, that it can't be a problem NOW - not an attitude I can take, myself, to be honest.

thanks in advance my lovelies!!

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  Post Number #2  
Old 19th June 2018, 06:48 PM
QAengineer13

 
 
Total Posts: 142
Re: Design and Development Exemption/NA confusion

Hi Kellylisa,

I am just curious after reading your post then what is the scope of your ISO 13485 you don't need to stated in exactly just paraphrase it so that the cover members can interpret the scope and the applicability of D&D.
  Post Number #3  
Old 20th June 2018, 01:30 AM
kellylisa

 
 
Total Posts: 8
Re: Design and Development Exemption/NA confusion

Quote:
In Reply to Parent Post by QAengineer13 View Post

Hi Kellylisa,

I am just curious after reading your post then what is the scope of your ISO 13485 you don't need to stated in exactly just paraphrase it so that the cover members can interpret the scope and the applicability of D&D.
Hi QAEngineer13


Our cert states "manufacture and distribution of bone cement mixing systems and ancilliaries…"

thank you
  Post Number #4  
Old 20th June 2018, 11:56 AM
yodon

 
 
Total Posts: 1,169
Re: Design and Development Exemption/NA confusion

I'm merely speculating...

Presuming your devices are Class IIa as you indicate, all I can think of is that they consider Design & Development an outsourced process. That, of course, doesn't relieve them of the compliance responsibilities.

Since you say they have a tech file (presuming fully populated - albeit maybe not up-to-date) then the reviewers may well have seen that the required contents were there and moved on without confirming they were current.

Is this not something you'd be comfortable discussing with your management team? Maybe they have insight that you've yet to discover?
Thanks to yodon for your informative Post and/or Attachment!
  Post Number #5  
Old 21st June 2018, 01:40 AM
kellylisa

 
 
Total Posts: 8
Re: Design and Development Exemption/NA confusion

Hi Yodon

thank you for your reply

It appears (after much digging, questioning and stressing) that yes - they DID consider it an outsourced process. however, it also appears that when the auditors were last here that they never got as far as either D&D or Manufacture of the product, as they went over their allotted time.
so this means that I will definitely have to go through it this year.

the technical file appears to be fully populated (if in a haphazard manner and probably not up-to-date) so you could be right...maybe they just didn't dig.

the company now wants to have more control over the D&D (having managed to get a decision from one of the Directors yesterday) which means that they will have to have something in place to ensure that this is monitored adequately and compliant - so i'm not quite off the hook yet, unfortunately! LOL

i'm in the process of trying to contact various consultants to acquire any files/designs/drawings etc that the still have on file (I hope they still have them on file!) so that I can put something together here. this should at least give us the option of 'shopping around' when it comes to future updates, without having to continue to go back to the same agents (some of which are no longer in the field, anyway)

thanks again for your input - very much appreciated.
I feel like i'm going around in circles, nobody here really understands HOW they kept getting away with it (as they put it) but continued to enjoy the fact that they DID
I now have to figure out how to best fulfil our new 13485:2016 requirements.

yippee!
  Post Number #6  
Old 21st June 2018, 08:19 AM
chris1price

 
 
Total Posts: 259
Re: Design and Development Exemption/NA confusion

I understand your frustrations but I am not surprised; having been audited by NBs over many years for both ISO13485 and MDD CE Marking, the depth and thoroughness of their audits frequently left much to be desired. I would like to hope that the requirements of the MDR will improve the diligence of the NBs.

However, ultimately, you have to rely on your own systems and good practices to ensure the products are well made and not be reliant on the NB audits.
Thanks to chris1price for your informative Post and/or Attachment!
  Post Number #7  
Old 21st June 2018, 09:13 AM
kellylisa

 
 
Total Posts: 8
Re: Design and Development Exemption/NA confusion

Agreed

it is extremely frustrating, i'm trying to close out things from their last audit as well as update the QMS and my starting-block keeps getting moved because I can't find proper information.

thanks all for your advice and input - it really has been helpful to 'sound off' at people who don't look at me like i'm speaking a foreign language
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