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  • ISO 13485 certification for suppliers

    I am confused, please advise. We are manufacturing medical devices. In our products, we are using a lot of components from other suppliers. We are implementing ISO 13485. 1. Does it mean that all our suppliers also have to have been certified with this standard? 2. How the notified body will decide whether to audit the supplier or not?

  • Document coding system

    We recently started with the use of your toolkit to implement ISO13485.
    I would like to get some advise about the use of document codes.
    Procedures are suggested to be PR-XX
    Record: PR-XX-Y (with XX the same as the corresponding procedure)
    But how would you differentiate: forms, sheets, workinstructions, reports,...
    In a previous company I used to work with SOP (standard operating procedures), WI (for workinstructions) , FORM (for forms and sheets), REP (for reports). This was ISO 15189.

    Can you advise what could be a good document coding system for the different records?

  • SOP related to IFU

    In the toolkit was not included any SOP related to the control of labels and IFU’s of medical devices.

    As it is obvious to us that we need such an SOP, could you provide me with a template of the procedure and the relative form?

  • ISO 13485 nonconformity

    I wonder if you can answer a question for me.  My company is a custom manufacturing company that does not make its own product.  We help our customers in the design of their product and also build product for them.  We are ISO 9001 & 13485 certified. 

    We have no change agreements in place with many of our medical device customers that clearly state if there is a change to process, documentation, components, tooling/equipment, etc. …we are required to notify them to (depending on the customer) make them aware or gain approval.  We also have medical customers where there is no such agreement.  One of these companies was recently purchased by a larger medical device company who provided notice that within a number of months, my company will be under a no change agreement, which we signed but is not applicable until July 2020. 

    A supplier audit was conducted by this larger medical device company at my company’s site this past March, in the audit results there is a finding for an internal change order that did not effect form, fit or function of the assembly and keeping in mind there is not a “no change agreement,” yet the auditor considered this a noncompliance. 

    I have perused ISO 1385:2016 and cannot find anything that would support this finding.  All of our procedures are in accordance with both 9001 & 13485.  Would you consider this a finding and if so, can you explain why?  I’m only looking to understand the perspective of the finding where there is not a “no change agreement” and we did not change material and the change did not affect form, fit or function of the assembly.

  • Class II

    is it an MDr requirement for an EU manufacturer producing Class II1 medical devices with a Valid DOC and the Notified Body mentioned on the DOC? sorry the requirement is for ISO13485
    let me rephrase is it a requirement for an EU manufacturer producing classIIa medical devices to have ISO13485. he has a valid DOC with a notified body mentioned on the certificate

  • Hand sanitizers under ISO 13485

    1. Is our production (hand sanitizer) is under ISO 13485? For now, it is considered a cosmetic category? 2. If no, may I know which ISO fits it?

  • EN 13795/ISO 13485

    We have a requirement for surgical gowns EN13795. The factory we are dealing with has confirmed that it is already certified for EN13485. Do the gowns from an EN13485 certified factory automatically meet the 13795 requirement or do they need anything more to reach 13795? Thank you for your help,

  • ISO 13485:2016/21 CFR 820 requirement question

    Is it part of regulations to provide auditors with employee(s) signed job descriptions if asked?
     

  • ISO 13485 or ISO 9001

    Would you prefer ISO 13485 for a Medical device company? to ISO 9001:2015?

     

  • ISO 13485 planning related query

    We are ISO 9001:2015 certified and would like to initiate ISO 13485:2016 QMS implementation. We manufacture molecular biology reagents for research use only. My query is if we implement ISO 13485:2016, we would still label the reagents as research use only and supply to research customers with the possibility of selling it to Medical device manufacturers as well? Am i correct in my understanding?
    Also, is 13485 product specific or for the processes?
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