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CMDCAS addition to ISO 13485

Discussion in 'Canada Medical Device Regulations' started by OrangeIsEnergy, Aug 14, 2015.

  1. OrangeIsEnergy

    OrangeIsEnergy Member

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    Hi all,
    Does anyone have a summary or comparison of ISO 13485 and what is required by the CMDCAS addition? My company is looking into licensing IVDD's in Canada (Class 3 according to Canada) and wants to know what it will take to modify our existing QMS... Thanks!
     
  2. GStough

    GStough Member

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    I have a cross-reference of ISO 13485, 21 CFR 820, JGMP, CMDR and IVDD. It's an attachment in our quality manual. Is this something that would be helpful for you?
     
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  3. OrangeIsEnergy

    OrangeIsEnergy Member

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    Yes! That would be wonderful! I need to present a timeline for updating our system for CMDCAS, so any info on the changes needed is helpful. I think you can just upload the file to a message here...
     
  4. Jan van der Kuil

    Jan van der Kuil New Member

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    Attached Files: 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your Own Risk:

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  5. GStough

    GStough Member

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    I'm sorry that it took so long to upload. Still catching up from 3 weeks' vacation. :eek:
     

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  6. OrangeIsEnergy

    OrangeIsEnergy Member

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    No worries! thank you!
     
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