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Virtual Manufacturer / OBL ISO Requirements
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Virtual Manufacturer / OBL ISO Requirements
Virtual Manufacturer / OBL ISO Requirements
Virtual Manufacturer / OBL ISO Requirements
Virtual Manufacturer / OBL ISO Requirements
Virtual Manufacturer / OBL ISO Requirements
Virtual Manufacturer / OBL ISO Requirements
Virtual Manufacturer / OBL ISO Requirements
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Some Related Topic Tags
european medical device regulations, iso 13485:2016, obl (own brand labeling), oem (original equipment manufacturer), qms (quality management system), virtual manufacturing
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  Post Number #1  
Old 9th November 2017, 05:17 AM
BenAMS

 
 
Total Posts: 1
Please Help! Virtual Manufacturer / OBL ISO Requirements

Hello, my company is an Own Brand Label (OBL) medical device manufacturer and are in the process of implementing a QMS and planning to market within the EU.
I would like to know if anyone has any advice/guidance on how to manage our sourced Original Equipment Manufacturers (OEM) per the new MDRs/ISO.
Any help/advice would be greatly appreciated.

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  Post Number #2  
Old 9th November 2017, 06:31 PM
Ronen E

 
 
Total Posts: 3,736
Re: Virtual Manufacturer / OBL ISO Requirements

Hello Ben, welcome to the Cove.

As far as I know there are no special provisions for OBL in the new MDR. Your org will be the responsible manufacturer, and you should manage your OEM as a supplier (obviously, wherever it matters it should be considered critical or the likes).

If you need close assistance in preparing for the new MDR please send me a PM.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 13th November 2017, 05:54 AM
pkost

 
 
Total Posts: 808
Re: Virtual Manufacturer / OBL ISO Requirements

As Ronen said, there are no specific provisions in the MDR for OBL/OEM. In fact there were never any in the MDD.

As a word of caution, in the past, OBL used to be a quick route to market, you could request some documents from the OEM, sign a Technical agreement, promise to collect and report complaints and pretty much forget about it.

Over the last 5 years of so, this lax attitude has progressively tightened. NB's started requesting more documentation; you must now stay on top of the documentation and maintain it (don't let it gather dust).

In the last year or so, I've frequently heard people say that OBL/virtual manufacture is dead. While I don't necessarily agree, it is certainly the case that the expectation is now that you are fully a manufacturer and must act as one.


In this vain, with regards to managing your OEM; you should manage them as you would any other supplier, however that may be. I would strongly recommend auditing them. You must be on top of document control, don't let your documentation gather dust, make sure they inform you of changes. It is a delicate relationship as they view themselves as the owner of the product/design, however while this may be true and accepted in the past, the regulatory authorities now view you as responsible and therefore in control.
Thanks to pkost for your informative Post and/or Attachment!
  Post Number #4  
Old 13th November 2017, 06:00 AM
Ronen E

 
 
Total Posts: 3,736
Re: Virtual Manufacturer / OBL ISO Requirements

+1 pkost
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