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  • Matrix for Requirements against Process/Department

    May I request the matrix for ISO13485:2016 Requirement against process/ department for Gloves Manufacturing (Non-Sterile Examination Gloves) is for the guide for Internal Audit.

  • MDR labelling

    Is it mandatory under MDR that labels and instructions of use to be translated in the languages accepted by the Member States of the Union where the medical device is going to be used by a patient? ( Article 10, subparagraph 11)
    Would a company be compliant under MDR if the label attached onto the medical device is only provided in English and has a list with the flags representing the EU countries for customer to refer to the applicable language in the IOUs?

  • Contamination/requirements for sterile medical device contamination intro vitro diagnostic device (IVD) (i.e. IVD)?

    I seeing in the 13485 requirements. would this requirement be applicable to IVD ? Currently we we are not sterilizing anything? Could you please provide a list of items that would require sterilizing in the process/lab per the clauses listed in the standard below? Arrangements for the control of contaminated or potentially contaminated product 6.4.2 Requirements for control of sterile medical device contamination 6.4.2 Thank you in advice. I am confused and need confirmation/clarity.

  • What in ISO 14534: 2015 should be applied to contact lens care products?

    I am interested in the following:

    What is it in ISO 14534: 2015 that should be applied to contact lens care products and not found in 
    93/42 /EEC?

  • Performing validation of process/activity

    How to perform a validation of the process/activity?

  • Implication of EU MDR Deadline on 26th May 2021

    Given that the new implemetaion date for the EU MDR is 26th May 2021, if this is not further postponed, would it imply that CE certifcations for all devices under MDD must be recertified under MDR before being allowed to import and sell in the EU?

    Is it applicable to all classes of medical device?
    What happens to the products that are already in the market/ in the stores or warehouses? 
    How would importer/wholesalers/end users find out if their products are CE certified under MDR?

  • Inventory management

    How is inventory management written in the ISO 13485?

  • Necessary facility requirements to build medical devices

    What facility requirements are necessary to build medical devices. (White rooms, etc.)

  • Can ISO 9001 lead auditor audit ISO 13485?

    Am a lead auditor in ISO 9001:2015 can it be difficult for me to audit the ISO 13485
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