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medical device registration, medical software
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  #1  
Old 10th November 2010, 03:17 PM
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Question Health Canada - EMR Software Update

Hello all,

Just an FYI for all those companies manufacturing electronic medical records software.

Health Canada originally mandated that these companies would be required to register their companies to the ISO 13485 standard, as the software is a medical device.

It's now looking like Health Canada will rescind this regulation for EMR providers. A colleauge of mine spoke with a Health Canada representative and they will be posting a bulletin outlining the new requirements later this month.

So, for those who have already started the implementation....what does this mean to your company? Will they continue with their registration?

Here's a link to the ITAC blog with the latest info:

http://www.itachealth.blogspot.com/
Thank You to vervecky for your informative Post and/or Attachment!

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Old 14th November 2010, 05:12 AM
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Re: Health Canada - EMR Software Update

Thank you !
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