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  • Cold Email

    Yes, cold emails are allowed under legitimate interest. If you have an email address of the procurement manager of a company that may be interested in your service, you are allowed to send a cold email because publishing the address on the company website as the referral for procurement affairs.

    Here you can find more information about legal basis:

    If you need to understand how to implement EU GDPR you may consider enrolling in our EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course/

  • Preparing SoA

    ISO 27001 only requires that results of risk assessment are taken into account when defining risk treatment and SoA, not that the majority of controls must have risks as justification for applicability (this is not a common situation, so you should be prepared for some questioning from the auditor).

    Provided that in the SoA you refer to the most relevant identified risks it can be accepted for certification purposes.

  • Question on SOA

    ISO 27001 doesn't require you to specify objectives in the Statement of Applicability - you can use some other document for this purpose. However, we felt that listing objectives next to each control in SoA is the most practical solution.

    Regarding the objectives, to make it easier, you can specify the objectives for groups of controls, very similar to what is written in Annex A of ISO 27001.

    This article will provide you a further explanation about Statement of Applicability:
    - The importance of Statement of Applicability for ISO 27001 https://advisera.com/27001academy/knowledgebase/the-importance-of-statement-of-applicability-for-iso-27001/ 
    - ISO 27001 control objectives – Why are they important? https://advisera.com/27001academy/blog/2012/04/10/iso-27001-control-objectives-why-are-they-important/

  • Business continuity elements

    Provided the EHS’s ERP is relevant to ensure the continuity of the services and/or processes required for business continuity it can be part of the business continuity efforts.

    These articles will provide you a further explanation about business continuity planning:

    This material will also help you regarding business continuity planning:

  • Do we need MDR?

    Considering the definitions of what is a medical device (Article 2 Definitions), to my opinion this is not a medical device. For some device to be medical device, it has to have some of the following purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.If I understand correctly your device, helps patients to feel more comfortable in the wheelchair, but it does not contribute to the healing of their health state.  

    If you look at your product from the point of view that your seating and brackets prevent developing pressure ulcers or similar skin changes, then it can be considered that seating and brackets are medical products. In that case, they are a class I medical device according to Rule 1 (Annex 8 Classification rules). In that case, it is necessary to implement the ISO 13485 Quality System and prepare the Technical Documentation in accordance with Annex 2 Technical documentation and Annex 3 Technical documentation for post-market surveillance.

    For more information, see:

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