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Certification to BS EN 62304:2006

Discussion in 'IEC 62304 - Medical Device Software' started by Quality Manager Liz, Oct 30, 2017.

  1. Quality Manager Liz

    Quality Manager Liz New Member

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    Hi, I am looking for advice on BS EN 62304:2006 Medical devices software – Software life-cycle processes. The company I work for create embedded software for a medical device manufacturer. I have been tasked with finding out how we gain certification to BS EN 62304:2006.

    From research carried out so far I have found very varied information; from you can’t be certified to it to a company that will carry out the certification as long as they carry out your ISO 13485 certification.

    We are currently certified to ISO 9001, ISO 27001 and ISO 13485 but our certification body do not cover BS EN 62304.

    Any advice gratefully accepted.
     
  2. Marcelo Antunes

    Marcelo Antunes Active Member

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    The standard was not created to be certifiable.
     
    Atul Khandekar likes this.
  3. yodon

    yodon Active Member

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    Agree with Marcelo that you can't (as far as I know) get your company certified to the standard. You can, however, have a product assessed for compliance. The test labs will do this for a tidy fee.
     
    Atul Khandekar likes this.
  4. Quality Manager Liz

    Quality Manager Liz New Member

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    Thank you for your response, this was my thoughts, just that there appear to be some companies that say that they do!
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Indeed. There are some CBs who will perform audits and issue something similar to a letter of conformity, for example...
     

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