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  • 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?

  • SOFTWARE VALIDATION In relation to ISO 13485:2016

    We have a query regarding SOFTWARE VALIDATION In ISO 13485:2016, Is it mandatory to have validation?
    Software vendor is not willing to provide us certificate

  • ISO 13485 planning related query

    As a supplier of reagents to a prospective medical device company, How would medical device file, advisory notice, risk analysis as per ISO 14971 be applicable for us?

  • ISO 13485 & EU MDR Integrated Documentation Toolkit

    How different or beneficial is this as compared to CEN/TR 17223?

  • State of validation

    State of validation of your templates, especially related to the new 14971:2019. Were already confirmed by notifying body, if yes - which one? I wonder if your consultants can cover risk discussion from a particular device, related to the particular risks affected by this new standard. 
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