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ISO 13485 & EU MDR - Expert Advice Community

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  • Amount of staff ISO 13485

    We have seen a reduction in staff in company due to reduction in sales and we are wondering how that can affect our ability to hold and maintain iso 13485. Are there any fixed numbers of staff that one must have to obtain iso 13485 and if staff continues to reduce, what actions should we take. For instance we have our iso certification next week and if we are approved for the iso13485, what can happen afterwards if lets say people decide to leave the company? We are a total of 5 personell today, what would happen if we are only 2 or 3? Should this be risk assessed?

  • Info packaging

    We import medical devices to *** from ***. *** product was CE certified under MDD and can be placed on the market under MDR. The question is how much the product is covered by regulations concerning information provided with the product (section 23 of appendix to MDR)?

  • Translation of IFU

    In order to have your instructions for use translated you have to ensure that the translation is correct a professional. We have a class III product only used by HCP's. We use a certified translation company who dispatches translation certificates (translated by native speaker with knowledge of the specific discpine and reviewed by a second reviewer). Is it correct that after the IFU has been translated an additional validation needs to be done of the translation by a subject matter expert (HCP) for each language?

  • Mandatory documents for SaMD to develop QMS

    I have a question for you, and want to ask for your opinion. We are an  AI software team in a *** hospital. Our product is similar to ***. Our pneumothorax algorithm could automatically identifies findings suggestive of Pneumothorax based on chest X-ray scans and outputs an alert. Because this product is a pure software, i.e. SaMD(Software and medical device), we do not manufacture physical medical equipment and don't have some activities. For example, there is no sterilization activity in our production processes. I would like to know what documents are mandatory for a SaMD to develop a QMS? Looking forward to hearing from you

  • Ang release of Product

    Which document in the ISO 13485 toolkit dictate release of product and who is responsible for releaseing? Cant seem to find it

  • Relevant documents for software medical device

    I think I know the answer to this question but I want to make sure. Are below documents relevant for a medical device that is a software or may I exclude them:
    • Appendix 4 – Request and Order for Purchasing
    • Appendix 1 – Product Specification
    • Procedure for Production and Service Provision
    • Appendix 4 – Notification to a Customer about Changes on Property
    • Procedure for EtO Sterilization
    • Procedure for Steam Sterilization
    • Procedure for Dry Heat Sterilization
    • Procedure for Ionizing Radiation Sterilization
    • Procedure for Filtration Sterilization
    • Appendix 1 – Record for Sterilization
    • Warehousing Procedure
    • Appendix 1 – Record for Temperature and Humidity Control
    Adding these documents too (which are marked as mandatory but they don't relate to an app?):
    • Appendix 6 – Record of Medical Device Installation
    • Appendix 7 – Record of Servicing Activities

  • Receiving CE Mark

    I consult a German company name ***. This company develop, manufacture dental implants and need the CE Mark soon in order to sell these items in Europe. We need to find a NB to perform an audit soon, and we can send the Technical File of the products to promote this process. We can be audited to ISO 13485-16 or ISO 9001-15 what is the best to achieve the CE Mask soon. How you can help us?

  • GSPR and IFU/manual

    In GSPR clause 23,4 it reads that manual must contain: (d) where applicable, links to the summary of safety and clinical performance referred to in Article 32;, Does this mean that I have to place a line that states: “For safety and Clinical performance summary- see link ###”. But this can be highly confidential information that I don’t want to share with user or potential competitors. How shall this be written in the IFU/manual?

  • Implementation ISO 13485 on making medical materials for medical laboratories

    For the ISO 13485, I know it is applicable for the manufacturing of clinical chemistry reagents since it is used for the diagnostics tests, is it correct?

  • Risk managment plan

    HI we are implementing 13485/9001 at the same time. We have a risk management plan and all within risk management for the medical device. However we also have a non medical deivece intended for industry  workerse. Does this device require risk assessment record for that product under 9001?
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