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  • 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    We have our own qms outdated as far as procedures is concerned but the specs and forms are being used ervery day.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)?
  • Does the medicinal product licence holder need to comply with ISO 13485 ?

    If a device is considered as integral in terms of a medicinal product (art. 117 MDR) and the device element is manufactured by a contract manufacturer, does the product license holder (for the medicinal product) also have to comply with ISO 13485?
  • May I ask which country can accept ISO 13485 and ISO 9001?

    ISO 13485 is accepted worldwide as a benchmark for Quality Management System evaluation for medical equipment. In specific, countries in Asia and the US are also adopting the ISO 13485 standards as part of their regulatory requirements.
  • Is ISO 13485 required if we manufacture non-medical parts?

    We are a plastics manufacturer. Most of our products are not for the medical industry, and we do not own those medical products (we do not manufacture medical devices), only manufacture parts for the customer. We are currently certified to ISO9001:2015 and are seeking ISO 13485. Question, do we need to have both certificates? Also, I am presuming that the non-medical parts would not need the additional requirements for medical devices, and through an audit.
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