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  • Question on ISO 13485 & MDR

    The reason of my interest is not that that I want or must have the ISO13485 certification, but my supplier (a medical device manufacturer) for whom I sell their devices already for over 10 years, is suddenly asking me a list of all my clients, as they say they must contact my clients in view of ISO13485 & MDR…?

    In my belief, this is not compulsory for them to do.

    Are you in agreement with me?

    As their rep. and sales office I can contact of course my buyers on their behalf, IF at all needed??

  • Implementation of ISO 13485

    Hello! My company is a small contract engineering group that offers medical device development services. Since we are purely R&D (no manufacturing) does it make sense for us to implement ISO 13485 in your opinion? Thank you for your time.

  • ISO 13485 Implementation

    If I have a certificate of ISO13485 (for my 1st factory) , and now i would like to expand my business to second factory , can i add a new facilities information on the available ISO ? or i have to apply a new ISO13485?

  • Medical Device Family

    Dear 13485Academy, we develop a software as a medical device in Class 1. We are about to develop a new device which has many many similarities with our existing medical device. It uses the same basic structure, design, etc.. However, the characteristics of the users are different, as well as the intended purpose (only slightly, but still). Are we allowed to only have one Technical Documentation for both our products?

  • Auditing Biomedical service providers

    I am the Regional Quality Director for Intl SOS in Africa. Lot's of our clients want to use service providers in Africa for servicing and calibration of Biomedical equipment. What are the minimum criteria I should ask for when auditing them?

    Qualification of Bio-technicians?
    Against which standard they are performing their calibrations? And btw, should this not be stipulated in the calibration certificates?
    Against which standards are their measuring and calibration equipment calibrated/standardized?

    This is but a few I can think of - can you please assist me with this as I want to create a procedure for verification of Service Providers for the region.

  • 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.

  • 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?

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