ISO 13485 & EU MDR - Expert Advice Community



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  • Is vendor agreement mandatory for ISO 13485?

    Regarding vendor agreements in ISO 13485 2016
  • What form of signature does ISO 13485 accepts

    The organization I work for is considering ISO 13485 certification in the future. Does ISO 13485 require hand written signatures or are electronic/digital signatures acceptable as long as we use a formal validation of the system for electronic signatures?
  • Exclusion of clauses for ISO 13485 for small business

    1. I have been told that small businesses of less than 5 employees can be excluded from some areas of IsO 13485. Can you let me know what these are please?
  • Organization of folder using Advisera template

    Would you advice to build the structure of the folders like you have provided (ex. 00 is the Procedure for Document and Record Control, the second is folder 01 the Project Plan, the next folder is the Quality Policy) or to have a structure that corresponds directly to ISO 13485 ex 4. Quality Management system, 5. Management responsibility, 6. Resource management etc) and store there the corresponding processes? What is more recommended for notified body audits?
  • Is ISO 13485 applicable to a non-profit organization?

    We are a non-profit organization that ships supplies and equipment to international partners throughout the world. We have recently been asked to provide documentation to prove our used/donated medical equipment meets ISO 13485 certification requirements. How can this be accomplished?
  • Is advisory notice applicable to a subcontract manufacturer ?

    Does Advisory Notice is applicable for the organization that produce product for other company (sub contract). should we create a procedure regarding this? Our organization not supply to end customer, but delivered to Main company first.
  • Merging of QMS with Advisera template

    We have our own qms outdated as far as procedures is concerned but the specs and forms are being used ervery day. Then we have the version bought ad advisera that could be merged somehow. But we have also a lot of stand alone procedures that are better or more suitable than no 1 and 2 merged. Actually it’s more like merging 2,5 qms where some cherry picking should be done. This merging is something that I would like to ( partly) outsource. Furthermore i am wondering if we should wait for this before we upload to conformio. We would be best served with document control ASAP regardless of current state of procedures. In short: merge first and then upload or upload and then merge. If you could tell us what best practice is, it would be very helpful.
  • Validation of IT Service Management System

    I am IT Manager in a medical device company.
  • How to get started with the documentation?

    How to get started with the documentation?
  • Applicability of ISO 13485 for medical device store

    Could you please give me a brief summary about ISO 13485 including its importance/applicability for a medical device store (not manufacture)?
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