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ISO 13485 Revision

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Marcelo Antunes, Aug 25, 2015.

  1. Sam Lazzara

    Sam Lazzara Member

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    Sue Place and Pads38 like this.
  2. Sidney Vianna

    Sidney Vianna Well-Known Member

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  3. Marcelo Antunes

    Marcelo Antunes Active Member

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    The group was asked to issue a transition planning guidance. In fact, regulators/certification/etc. seems to have a difficult time in correctly analyzing the impact of new or modified standards, so much so that IEC was asked years ago to include a suggested transition in each standard.
     
    Sidney Vianna likes this.
  4. MarkMeer

    MarkMeer Well-Known Member

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    I still can't believe the price difference! Considering purchasing, but want to confirm:

    For those of you out there who've purchased standards from the Estonian standards body in the past: Aside from their licensing, are there restrictions on the PDFs?
    I notice they require the FileOpen plugin to be able to view their PDFs. As I understand, the FileOpen plugin can be customized to different levels of file "lockout" (printing restrictions, screenshots disabled, ...etc.).
    I want to confirm: does their level of PDF security preclude copy-and-pasting text? It's important to me that I can still copy text, as I intend to use the standard to make my own gap-analysis checklist....
     
  5. Pads38

    Pads38 Member

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    Hi Mark,
    I have bought from Estonia several times. As you note their standard (and cheapest) offering is the single user version requiring the use of the FileOpen plugin. This has caused problems, such as not being able to view the pdf on an android tablet, as we couldn't get a suitable plugin.

    However, if you chose a 2-user version you are allowed to store the ordinary pdf on a network and can access it without any technical limitations. Copy/Paste works fine. As the company I work for is small it is unlikely that any more than 2 people will ever want to view the file simultaneously.

    The 2-user version is more expensive - for 13485 it goes up to 28 euro. Well worth it my book.

    Estonia also have a useful standards 'rental' option. For 2 euro you get access for one day to the whole standard. This helps when you are not clear as to whether a particular standard will be useful.

    The other Baltic states also publish key standards at 'discount' prices. I believe that this is to, effectively, subsidise their domestic manufacturers.
     
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  6. Sue Place

    Sue Place New Member

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    For anybody who is interested I have downloaded a copy from the Estonian link for a multi-user licence for about £21.00 very easy to do. Thank you goes to Sam for the link and Pads38 for the confirmation.