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ISO 13485 & EU MDR - Expert Advice Community

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  • Clinical Evaluation for Class A Medical Software

    Is Clinical Evaluation for Class A Medical Software mandatory during submission for certification related to ISO 13485:2016

  • MDR - difference between configurable device and device with accessories

    I am working on the documents to comply with the MDR for our products. I'm a bit confused about what applies to my case: We send a kit with a main device and some parts that can optionally be attached to the main device for certain patient groups to fulfill the intended purpose of the main device. So some patients will need the parts on the device, others not. Can we call this a configurable device or is this a device with accessories? And if this is a configurable device, when would this have been accessories? If I understand it correctly from the MDR, we need a separate Declaration of Conformity and Technical file for accessories, but not for components of a configurable device, right?
  • Declaration of Conformity according to MDR

    Is there a template to follow for the Declaration of Conformity according to MDR?

  • Questions about the implementation

    1. When the ISO needs to be finished / audited? (e.g. when company is founded, when first device is sold or…? – E.g. Section 7: Product Realization is with planning etc. is running right now while the company is not yet founded.

    2. Is English as language enough or is the country language additionally necessary?

    3. Is the IVD guideline 98/79/EG (IVDD) and/or German “In-vitro-Diagnostika-Verordnung (IVDR)“ additionally necessary and incorporated in your toolkit? If not, can you recommend a toolkit for this? Background: In simple terms, the product is a special microscope with which a view of a tissue sample can be created and viewed. The interpretation of this image is done by a pathologist (unlike, for example, a blood pressure monitor, where the device interprets something). Staining of the tissue sample is done outside the device using standard procedures/products from appropriate manufacturers (e.g. H&E staining).

  • ISO 13485 implementation

    Thank you very much for letting me put my question. My main concern right now is, is it possible to prepare all the required documents without letting expansive consultant to do it for us? What would be the challenging part while preparing document by company staff? If we use Advisera Templates and experts advice for preparing our documents, how much time will it take to get thing done for class IIa medical device?

  • Requirement for Post Market Surveillance

    We manufacturer Class 1 medical devices and I am wondering what we are required for the Post Market Surveillance procedure?
    https://i.imgur.com/JX9yTP9.png

  • Integration ISO 13485 & ISO 9001

    I have already purchased the toolkit of ISO 13485 + MDR and
    I noticed that in the Procedures there are references to ISO 9001.

    But I don't see an ISO 9001 + ISO 13485 integrated toolkit on your website,

    so if I want to get the ISO 9001 toolkit,

    should I still keep it separate from ISO 13485?

  • Post-market surveillance

    I wonder if you can help me with one question, please? I have read that ISO 13485 2016 places emphasis on post-market surveillance, and this terms appears in the glossary. Yet I cannot find this term in the text of the standard, although I suppose the meaning is in Section 8. Is there anywhere in the standard that actually asks for post market surveillance please?

  • Vigilance

    Vigilance is one requirement for MDR but cannot be found in the template. Is Vigilance included in 18_Post_Market_Surveillance?

     

  • Toolkit content

    I would like to ask about the documents included with the "ISO 13485 & MDR Integrated Documentation Toolkit toolkit with expert support" 
    We are a company with class I medical devices and are in the process of creating the SOPs to be compliant with MDR
    Are your SOPs geared towards medical devices with higher classes (therefore more detailed and technical) or are they also suitable / can be modified for class 1 devices
    For class 1 medical devices, we need to do SOPs for regulatory strategy; final product release; vigilance; and field safety corrective action. I don't seem to see those in the list of SOPs via the preview, and wanted to check if those are included or under a different name?

    Also, does your company provide a way to identify in the SOPs which part of the relevant SOP is necessary for Class 1, and which parts are not? As we will likely only want to include the necessary info and not give extra unnecessary info.

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