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  • 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?
  • PPAP, FMEA, QP, PSW in ISO 13485 toolkit

    I work as a Quality Engineer EU MDR for *** and they have ISO 13485. Will your course and  ISO 13485 Toolkit cover PPAP, FMEA, QP, PSW etc as this will be part of my job role in Supplier Quality Assurance?
  • Implementation ISO 13485 on making medical materials for medical laboratories

    Can we use ISO13485 in the materials industry for medical laboratories?
  • Classification of reusable orthopedic instruments used to fit implants

    in which class are reusable orthopedic instruments used to fit implants classified ? A drill bit or reamer which are attached to a power drill in which class would they fall? A jig used in knee surgery which is used to take knee cuts would fall in which class Retractors, Gouges ,forceps would be in which class Gamma biological indicators used to check sterility of batch after gamma irradiation would fall in which class Please give rationale for selection of each class
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