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Tag: "Product: ISO 13485 & MDR Integrated Documentation Toolkit" - Expert Advice Community



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  • MDR vs CFR 21

     “Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”  

    Gap analysis MDR vs CFR 21 

  • ISO 13485 toolkit ref 11

    I wonder if you can give me some guidance on ISO 13485 toolkit ref 11 procedure for production and service provision. As we are a distributor the only part I seem able to answer on here is 3.3.7, because I can relate that to the batch and serial tracking once we have received the goods through to their delivery at customer. I know the QMS says various parts of 7.5 can be excluded. But I am not sure if need to fill in more in order to be complaint?
  • Purchasing and Evaluation of Suppliers

    I was hoping you could answer a question for me, I am looking at section 10, Purchasing and Evaluation of Suppliers. I am confused with 3.3 and 3.4. Is this referring to new suppliers that we are in the process of selecting? Already approved suppliers? Or both? The reason I ask is I am unsure how you can analyse previous purchasing and shipment quality of a new supplier.
  • Ang release of Product

    Which document in the ISO 13485 toolkit dictate release of product and who is responsible for releaseing? Cant seem to find it
  • 3.6. Documents of external origin

    1. In  the section 3.6 Documents of external origin- in Procedure for document and record control. There is a line saying- “Each external document that is necessary for the planning and operation of the QMS must be recorded in the incoming mail register “ This is basically all emails, from purchase, sales, quality etc etc. basically everyone email that needs to be registered because it can be necessary for the planning and operation of the QMS. This makes it completely inefficient to run the company. What is the absolute minimum to do here?.  We have several different systems that track important emails and documents. We have a program for QMS- to handle all documents- we have a ERP system to track all sales/production/shipments. This email registering system will break us. Why do we need it? Please advise. 2. In iso 13485. It only states: “ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled” SO why does the tookit refer to that we have to have an advanced document email document system.
  • Technical file and clinical evaluation

    With the combined package for ISO 13485 and MDR, do we need any external assistance with the technical file and clinical evaluation? i.e. a healthcare professional
  • 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).

  • 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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