#1
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.
 

Gert Sorensen

Forum Moderator
Moderator
#2
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A Quick Bump!

Can someone help pfcustodio?

Thank you very much!!
 

somashekar

Super Moderator
Staff member
Super Moderator
#3
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.
 
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Pads38

Quite Involved in Discussions
#4
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)
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&rc...4oDwCw&usg=AFQjCNH6VE-ZXF2whhdsxL-h33Wu3gAOMA
 
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