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  • 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
  • KPIs

    We are in propcess to finalize ISO 13485 in our company(electronic industry), at the moment we still didn't define KPI. Could you be so kind and suggest me which are tipical KPIs ? We need ideas to define KPI for our core bussines: Development_Production-Sales_marketing of electronics. ISO 13485 requires to define special KPIs just for MEDICAL PRODUCT. If you have one examopl for me or one example like excel table it will be very helpfull for me.
  • Gap analysis and key performance indicators

    1. How to conduct gap analysis for ISO 13485? 2. How to determine key performance indicators?
  • Classification

    Just a quick question. If I have equipment that generates oxygen for medical applications, and the machine only generates and fills the oxygen tanks, which are then used in hospitals, etc, is the generating equipment a medical device? If so, what would be the classification? It sounds to me a bit like equipment that is used to manufacture medicines for instance, and in my opinion it should not be classified as a medical device. Your input will be greatly appreciated. We need to urgently clear this, because my client is importing the equipment to ***, and we need to know what registrations, etc, we need to apply. It is because medical devices are regulated in ***, but we apply more or less the same requirements as the EU.
  • Checklist for medical device labeling including advertising and claims

    How to audit and create a checklist for medical device labeling including advertising and claims
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