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  • 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?
  • Stage 2 audit requirements

    We have a Stage 2 audit scheduled for March. The scope of our certification is the control of manufacture as we are intending to outsource all manufacturing. We don't yet have the manufacturers onboard and are arranging Quality Agreements with them now.
  • Is European certification equal to ISO 13485 ?

    I have a question about ISO standard adaptation for the European company.
  • Establish QMS compliance to ISO 13485 as a reagent manufacturer

    We would like to establish QMS compliance to ISO 13485 in anticipation of business with IVD company wherein our reagent would be a part of their IVD kit. (We will not be involved in the manufacturing of any IVD per se) How would clauses which are specific to a medical device like medical device file, advisory notice, risk analysis, complaint handling etc as per ISO 14971 be applicable for us?
  • Certifying a family of products under ISO13485 when company is ISO 9001 compliant

    Hello, Currently we are certified under ISO9001:2015, however in the next months we pretend to certify a family of products under ISO13485.
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