ISO 13485 & EU MDR - Expert Advice Community



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  • Masks effectiveness

    Are all the masks produced under the mentioned standards effective against the COVID-19?

  • Standard for protective equipment

    I try to download the standard for "Personal Protective Equipment" and Medical Device. I am not sure I found what standard the manufacturer might to comply with.
    If we are wholesale and distributor, I also need to know how kind of certificate we have to request from our suppliers.

  • New regulations to general PPE

    Obviously these have been fast-tracked because of the current crisis, but I wondered do these new regs apply to general PPE in industry

  • ISO 13485 N95 Face Mask

    ISO13485 N95 Face Mask - is this considered a class two device? ISO 13485 tested and approved N95 Face Mask - would this be considered an FDA approved class two device?

  • ISO 13485 implementation time frame

    How much time would be needed to "adjust" the toolkit to a company? I know this is not an exact science, but maybe some comments
    would help. I expect you to have quite a base of users to give you some idea. 

  • 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?

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