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  • ISO 13485 and ISO 9001

    I am in the process of implementing ISO 13485 using the templates from Advisera.  Our parent company is also implementing ISO 9001:2015 at the same time. The global procedures of 9001 seem to overlap with the global procedures of 13485 (i.e. Quality Policy, etc). My question is in regards to implementing both of these certifications simultaneously, while avoiding double work. Do you have any suggestions on what parts of ISO 13485 overlap with ISO 9001 and visa versa? What takes precedence?

  • 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?
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