ISO 13485:2015 Pre-Release News and Discussion

What were the results of the vote?

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It was approved, the information is being circulated in a while for WG members.

Fasten your seat belts, the fun begins!!!

Ronen E said:

Fasten your seat belts, the fun begins!!!

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Very true

Thanks this is very valuable. Is there a way to subscribe to this thread ? please advise.

You have probably been "subscribed" since you posted in it. It's the default option but can be changed in your User Control Panel > User Options (Look for "Default Thread Subscription Mode")
In any thread you visit, if you look above the first post in the thread, or in the first post on a page of a long thread, there is a link that says "Thread Tools". It is a drop down menu. One of the options is "subscribe to this thread" if you aren't already, or if you are the option will read "Unsubscribe from this thread".

This is the Instruction - (broken link removed)

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Another quick update: the comments document was circulated: 861 comments. It seems we will have a lot of work in Denver...

Marcelo Antunes said:

Another quick update: the comments document was circulated: 861 comments. It seems we will have a lot of work in Denver...

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This standard seems to have gotten lot of comments ... is this usual to have so many comments at different stages ?

For important standards like this, yes. For example, when IEC 60601 was revised for the Third Edition, the average number of comments for each draft was something like 2000 or 3000.

We all appreciate the updates Marcelo.
Do you have a recommendation for buying DIS 2 now or wait for FTIS? (and when would DIS 2 actually be available?)
We are considering a number of changes to our QMS and would prefer to move in the right direction before the Standard is released by reviewing the latest version.

Do you have a recommendation for buying DIS 2 now or wait for FTIS? (and when would DIS 2 actually be available?)
We are considering a number of changes to our QMS and would prefer to move in the right direction before the Standard is released by reviewing the latest version.

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DIS2 will be changes in a few days (in the June Denver meeting of WG 1), so I don´t think it´s a good idea to get it now. The FDIS will be available some months after June (if it´s decided to go to a FDIS, but judging from the last discussions and also for the comments o DIS2, I´m pretty sure we will have a FDIS).