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ISO 13485 & EU MDR - Expert Advice Community

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  • 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?

  • ISO 13485 Manufacturing

    ISO 13485, Manufacturing of Thermometer, Ventilator, BP Measurement apparatus - what are the applicable regulatory requirements?

  • ISO 13485 certification

     I work for *** in the UK. I am trying to find out if I can import 4 ply face masks from a supplier in Vietnam that has the ISO13485:2016 certificate. I don't know if this is adequate or if the masks need to comply with EN or EU regulations.

  • Control of infrastructure

    I read your article on Managing Medical Device Infrastructure and we are wondering to what level of detail and validation we have to go. For example, we have measuring equipment that requires calibration, so we create validation records for each piece of equipment, including calibration schedules and service schedules. We also have a large volume of software, for example document writing, spreadsheets, ERP systems, Finance system, etc etc etc. We also have computers for development that our development team uses, computers for service delivery that our programmes run on. The same question applies, we wonder if we need records for each computer, each desk, each software package. Can you provide any clarity in this area for us at all?

  • Postponing Management Review

    We perform our Management Review on an annual basis and we always try to do it in May if I have to postpone it to August this year. Is that a problem?
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