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ISO 13485 & EU MDR - Expert Advice Community

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  • Documents for distribution company

    1. We are trying to determine which documents in your  'ISO 13485 & MDR Integrated Documentation Toolkit'  are required for a 'distribution company' distributing medical devices. Understanding this more clearly will help to us to secure funding to purchase.

    2. For use of this pack for a 'distribution company', can you please update your 'ISO 13485 & MDR Integrated Documentation Toolkit' document with an additional column indicating which procedures would be needed. This will help to convince management on the necessity to purchase the pack"

  • Electronic signatures

    Hello, I was wondering if you have workflows and electronic signatures for the 13485 module and if they are 21 CFR 11 compliant.

  • MDR 2017/745

    Liability Insurance
    what kind of insurance is that?
    which insurance companies are available for that?

  • Bar codes under MDR

    What are the guidelines for bar codes on single use, sterile medical products under this new MDR?

  • Regulatory requirements

    As we discussed - we need to fulfill regulatory requirements both in Europe (MDR) and USA (FDA - class I and class II product). If we implement ISO 10328 will we be OK with FDA requirement according to FDA: 21 CFR 820 and possibly other requirements 21 CFR 806, 807, 830 and 21 CFR 11

  • EU MDR

    Does the EU MDR apply outside of the European Union? If so, does it apply to the Republic of Trinidad & Tobago?

  • Vendor Audit

    We are into manufacturing of medical devices, is it necessary/mandatory to audit vendors which are critical?

  • HDS

    Can an HDS be done between countries?
    I mean can we store medical data in a country and use the date in another country?

  • Toolkit content

    Are the procedure numbers cross-linked in the documents-kit? For example, the product validation document will refer to several documents, e.g. product development plan, risk management, verification & validation procedures, etc.  Do all these procedures have numbers/codes already implemented and cross-referenced or do I have to do the work?

  • ISO 13485 and IVD

    I have a question about IVD
    if I have an in vitro diagnostic device intended for professional use not listed in annex II of IVDD 98/79/EC
    and I want to sell the product in other countries instead of EU but these countries require that the product to be CE mark (customer in XYZ for example)
    can I issue the self-declaration and put CE on the product without authorized representative?
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