ISO 13485:2015 Pre-Release News and Discussion

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stevenking

Starting to get Involved
#84
Hello all

Just some quick news, ISO 13485 is going to be revised, a decision was made on the meeting of ISO TC 210 WG 1 this week. There's at least some 17 topics which are going to be revised or enhanced. A new work proposal will be circulated within the next month or so, along with a user survey on other possible changes.
Dear Marcelo:
Hello!
How about the clinical comments in ISO 13485:2015 drafting? In China, all class II/III Medical Devices are needed to undergo clinical trial for the initial registration. it is more rigorous than other coutries'.
Thanks a lot!
 

Marcelo

Inactive Registered Visitor
#85
Dear Marcelo:
Hello!
How about the clinical comments in ISO 13485:2015 drafting? In China, all class II/III Medical Devices are needed to undergo clinical trial for the initial registration. it is more rigorous than other coutries'.
Thanks a lot!
Hello, ale welcome to the Cove.

The clinical requirements as about the same in the draft: if required by the target regulatory system, they have to be performed. But it?s only a general remark, because the standards is not related to any particular system.
 

stevenking

Starting to get Involved
#86
Hello, ale welcome to the Cove.

The clinical requirements as about the same in the draft: if required by the target regulatory system, they have to be performed. But it?s only a general remark, because the standards is not related to any particular system.
Great! Thanks,
Would you please tell me when the FDIS will be issued, and where we can get the comment discussion materials?
 

Marcelo

Inactive Registered Visitor
#87
Would you please tell me when the FDIS will be issued
Probably in the end of the year or in the beginning of 2015. if everything goes as planned.

where we can get the comment discussion materials
They are only available to members of ISO TC 210 WG 1 but can be get thru NCs too.
 

stevenking

Starting to get Involved
#88
Probably in the end of the year or in the beginning of 2015. if everything goes as planned.



They are only available to members of ISO TC 210 WG 1 but can be get thru NCs too.
Thanks,
The current format of ISO 13485 might not be acceptable given that the next edition of ISO 9001 is due for publishing in 2015 and this follows the Annex SL format – High Level specification for Management Systems Standards. It is expected that all Management System Standards would follow this format.
Right?
 

Marcelo

Inactive Registered Visitor
#89
The current format of ISO 13485 might not be acceptable given that the next edition of ISO 9001 is due for publishing in 2015 and this follows the Annex SL format ? High Level specification for Management Systems Standards. It is expected that all Management System Standards would follow this format.
Right?
Even if mandatory, there?s no requirement that documents already in process of being revised use this structure. But the next revision will have to use it (if the high level structure is maintained in the future).
 
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