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ISO 13485 & EU MDR - Expert Advice Community



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  • 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    We have our own qms outdated as far as procedures is concerned but the specs and forms are being used ervery day.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.
  • Design Control Documents

    Our previous attempts at drawing up design control documents were met with criticism from the auditor. Would you be able to email me an example of an approved design control document for ISO13485:2016. We need to improve the format too so a template would be great if you have one. I need help defining the user requirements, inputs, and outputs.
  • Different standard for sampling?

    I recently joined a medical device company that still uses the MIL standard for sampling. Is that acceptable? I am only used to ANSI at this point
  • Can the preparer be the reviewer and approver for clause 4.2.3?

    Per ISO 13485 clause 4.2.3 requirement, shall the document preparer, reviewer and approver are the different people?
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