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OBL (Own Brand Labelling) - Technical Files/Risk Management
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OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
OBL (Own Brand Labelling) - Technical Files/Risk Management
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ce mark and ce marking, class ii medical device, class iii medical device, iso 13485 - medical device qms, obl (own brand labeling), portugal, product realization
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  Post Number #1  
Old 26th February 2014, 12:53 PM
pfcustodio

 
 
Total Posts: 3
Please Help! OBL (Own Brand Labelling) - Technical Files/Risk Management

Hi to all. New here but I have already read a lot.

I'm in a company since February, which is a OBL (Own Brand Labelling) and seeks certification by ISO 13485. The company is in Portugal (Europe) and has IIa devices, IIb and III devices.

We have the OEM agreement, CE marking and technical files. The questions are:

The provided technical files consist of a maximum of 3-4 pages, ie, it is not the technical construction file (which is the know how of the OEM). Are the technical files sufficient in terms of certification (for the CB)?

And about the risk management, as OBL, how should I address this point as it relates to product realization?

Thanks.

Note: My experience focuses primarily on quality management systems.

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  Post Number #2  
Old 28th February 2014, 03:08 AM
Gert Sorensen's Avatar
Gert Sorensen

 
 
Total Posts: 1,278
Re: OBL (Own Brand Labelling) - Technical Files/Risk Management

--------------------------------------------------------------------------------

A Quick Bump!

Can someone help pfcustodio?

Thank you very much!!
  Post Number #3  
Old 28th February 2014, 06:47 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,345
Re: OBL (Own Brand Labelling) - Technical Files/Risk Management

Quote:
In Reply to Parent Post by pfcustodio View Post

Hi to all. New here but I have already read a lot.

I'm in a company since February, which is a OBL (Own Brand Labelling) and seeks certification by ISO 13485. The company is in Portugal (Europe) and has IIa devices, IIb and III devices.

We have the OEM agreement, CE marking and technical files. The questions are:

The provided technical files consist of a maximum of 3-4 pages, ie, it is not the technical construction file (which is the know how of the OEM). Are the technical files sufficient in terms of certification (for the CB)?

And about the risk management, as OBL, how should I address this point as it relates to product realization?

Thanks.

Note: My experience focuses primarily on quality management systems.
Hi and welcome to the COVE.
You are an OBL company and so you do not include design and development in your QMS. So you have no design file and technical construction file. Surely you will have access to the OEM technical files and other documents in case regulatory requires and so will be covered in the contractual agreement.
Your agreements can help you as controls in the various other product realization processes.
Risk management is throughout product realization, however your product realization includes your OEM's as he manufacture's for you, with his know how. Can you get a copy of the OEM's risk management and own it with your additional risks that you may assess from your processes. This can be a part of your OEM agreements, which you can consider adding if not included, with consent of your OEM.

Last edited by somashekar; 28th February 2014 at 01:06 PM.
  Post Number #4  
Old 28th February 2014, 07:31 AM
Pads38

 
 
Total Posts: 751
Re: OBL (Own Brand Labelling) - Technical Files/Risk Management

Our Notified Body presented a web-seminar a couple of months ago addressing changes in auditing and assessment brought about by European Commission recommendations.

I have a note from that webinar which states "OBL must have access to all technical documentation".

The webinar was delivered by a very senior person within the world of NBs, involved with the co-ordination group, NBOG, so you can expect this to be common to all NBs.

This is an extract from the EC guidance: (Annex II)
Quote:
Notified bodies should note that manufacturers:
(a) have to fulfil their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;
(b) do not fulfil their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system;
The full guidance is here:
http://www.google.co.uk/url?sa=t&rct...xL-h33Wu3gAOMA

Last edited by Pads38; 28th February 2014 at 07:40 AM. Reason: Link added
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