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ISO 13485 & EU MDR - Expert Advice Community

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  • Is technical file of device mandatory to put on device on market?

    I was reading the full text of MDR, in this regard, if I have correctly understood: the technical file of the device is mandatory to be registered by an EU manufacturer or its representative. Once this is done in the EU country of the manufacturer or representative, the device can be put on the market in ALL  EU countries (not only the country where it was registered). Am I right?

  • Applying Project Checklist for ISO 13485:2016 Implementation in a food processing organization

    Can you apply your Project Checklist for ISO 13485:2016 Implementation in a food processing organization?

  • Mandatory information in Conformity Declaration for Medical Device Class I

    Hello, I have a Conformity Declaration from a supplier for MD Class I non-sterile, under MDR 2017/745, that identifies the product with "name", "model" (uses the references of the products), "GMDN" and "Classification" (Class I). There is already a text field for "Basic UDI-DI", but is still empty. Recently I asked for a new product class I with a new reference, produced only for us. I asked for an update of the Conformity Declaration and the supplier told me the one I have is enough for the new reference because it is under the same "Name" and "GMDN". Is that correct? Doesn't the  MDR oblige to an "unambiguous reference allowing identification and traceability of the device", for this one in particular? Shouldn't the supplier add the new "Model"? Additionally, when will the Basic UDI-DI be mandatory in these declarations? Thank you, Isabel Sottomayor
  • ISO 13485 Internal Auditor

    As I work through the course material it is becoming increasingly clear that as a small company like mine-my ability to act as an internal auditor may not be feasible as I cannot audit the processes I am involved in.  I am also Purchaser and QMS Manager.
    It would not be possible for another member of my team to audit purchasing processes as they are not qualified.  We received a finding on a past audit as our Internal Audit was deemed unqualified.
    Please advise how other small companies navigate this situation.

  • Do we need ISO 13485?

    We are a manufacturer of cleaning chemicals, some of which are used in the medical industry, for cleaning medical devices, apparatus, equipment, etc.

    We have always been led to believe that we needed to adhere to ISO 13485 however, upon reading the document, I am not sure that it applies to us. Can your expert provide further clarification please?

  • Labeling of medical device accessories

    I am looking for information on labeling of medical device accessories. Specifically, we have a handpiece to improve delivery of laser energy from the fiber to the patient tissue. The notified body (under MDD) advised us to put the same laser safety labels on the handpiece (laser class, etc) as we already have on the laser itself. I cannot find any advise like this in the standards (IEC60601-1, IEC60601-2-22, IEC60825-1)

  • Questions regarding Technical files 13485/MDR

    1: Do we need a Technical File for outsourced products that are manufactured elsewhere?

    2: Do we need a Technical File for products that we relabel?

    3: Do we need a Technical File for products that we do not adapt or manufacture ourselves but that we buy and resell (as part of one of our products)?

  • MDR article 120 significant changes

    I need your support on an issue, we changed the contact sterilization supplier of our class I sterile product.
    Is this significant change according to MDR article 120?
    I need to do a decision tree evaluation on this,
    I need information on this topic.

  • Relation of GxP to MDR in Medical Software

    What I was looking for is the relation of GxP to MDR in Medical Software, do you have anything that helps me understand the relationship better?
  • Clause 8.2.6 ISO 13485

    Hello From ISO 13485 with MDR, in 11 Production and Service Provision, is there enough in this document to cover off 8.2.6. Document 11 does not mention 8.2.6 as a reference document.  But I do not see anywhere else that does either. thanks
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