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  • Question about training

    1 - I wanted to know for the Security Awareness Training, if we have our own training, can this be used and we just have to log when the training was completed? Who should participate in the training as all employees take this training.

    You can have your own training, but you need more than a log when the training was completed. You need to identify the training content and results achieved (e.g., who has participated, by means of attendance lists, who was approved, by means of exams results or certificates, etc.). In your toolkit, you have a Training and Awareness plan, located in folder 9 Training and awareness, that will help log all information you need to be compliant with ISO 27001 related requirements.

    Regarding whom needs to participate, you need to identify which security competencies need to be fulfilled, so you can identify who needs them. These are the people who need to attend the activities.

    For example, if you need to fulfill a gap related to clean desk and clean screen, may all employees in the scope will need this one. On the other hand, if you need to fulfill a gap in network security, maybe only IT personnel need to attend the activity.

    For further information, see:

    2 - It's from a site KnowBe4. I wanted to know for this part can our employees use this site or they have to use your site for ISO? Do we have to show who has had training?

    ISO 27001 does not prescribe how to perform awareness and training, so organizations can use their own training/awareness material, use a training provider, or adopt a mix of these approaches.

    Regarding training providers, you can use anyone you see fits your needs.

    Regarding records to be kept, the same records you keep when you perform training by yourself need to be kept.

  • Classification

    To my understanding of this equipment, equipment that generates oxygen for medical applications is not a medical device. A medical device is the oxygen tank if that oxygen has a medical device purpose and not as medicine.  

  • Checklist for medical device labeling including advertising and claims

    The best way to prepare the audit checklist is to go through the Annex 1 General safety and performance requirements of the Medical device regulation MDR 2017/745. There in Chapter 3 – Requirements regarding the information supplied with the device you have all requirements that need to be covered in labels and instructions of use

    For more information, see:

    • EU MDR Annex 1 – General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/

    • Missing documents

       Please note that controls A.12.4.1 (Event logging) and A.12.4.3 (Administrator and operator logs) are covered in template “Security Procedures for IT Department”, located in folder 08_Annex_A_Security_Controls >> A.12_Operations_Security

      Regarding controls A.12.4.2 (Protection of log information) and A.12.4.4 (Clock synchronization), please note the ISO 27001 does not require every applicable control to be documented, and in such cases, a short explanation about its implementation included in the Statement of Applicability will be enough (you can find documented information about these controls in the SoA template located in folder 06 Applicability of Controls).

      This article will provide you a further explanation about controls documentation:

    • Is ISO 9001 mandatory for company distributing medical devices?

      No, ISO 9001 is not mandatory for the companies distributing medical devices. However, in the ISO 13485: 2016 standard in section 0.1 Introduction - General it is stated that the ISO 13485:2016 standard can be used by an organization involved in one or more stages of the lifecycle of a medical device including design and development, production, storage and distribution and so on.

    • Implementation questions

      1. Do I need to perform mechanical tests on the liner? If so, which organization can do this?

      You are the ones who determine the tests that need to be performed on your product. If this test is crucial to show that your product meets the specifications, then a test is needed.

      As for the laboratories where the test needs to be conducted, MDR requires it to be some accredited institution.

      However, we are not authorized to refer you to the appropriate institutions because we do not know your product and its specifications.

      2. How long do I need to do clinical trials on the liner? How many months and how many patients need to wear the liner as part of the clinical trials?

      Clinical trials for medical devices must be prepared in accordance with the standard ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice. How long the research will take depends on many factors, which are listed in this standard.

      However, please be aware that clinical trials are necessary for those medical devices that are completely new and that there is no other source for clinical data. So, usually, it is for completely new types of medical devices, with new technologies or materials.

      For all other medical devices, it is possible to perform the clinical evaluation with the available clinical and scientific data for the literature (Article 61 in the MDR 2017/745). If I understand what silicone prosthetic liner is, it is not a new device, therefore you can find a lot of clinical data on the internet. When you use literature data for your medical device, you need to find an equivalent device with which you will compare your medical device. Equivalence must be demonstrated at the clinical, technological, and biological levels.

      For more information, see:

      On the following links you can find how we have prepared in the ISO 13485&MDR Documentation toolkit documents and reports for clinical evaluation:

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