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  • Multiple titles

    Under ISO 13485, would the FDA have a problem if the CEO of a company would also have a business card that shows him or her as a business development representative? Two business cards with two separate titles?

  • Applicable exclusion from standard

    We manufacture IVD Rapid Test Kits (Malaria pf, Pregnancy etc.). As you can see on the attached, our medical device manufacturing processes involved Purchasing (Raw Materials), Cutting, Assembling, Sealing, Packaging & Labeling and Marketing & Sales. We do not service our devices and there is no software validation. What exclusion from the standard is applicable in our situation? Hope to hear from you soon


  • Quality manual & Procedure under the ISO 13485:2016

    I am newly join to a medical device supply company which under the restructuring the management and nature of its businesses. The company has certified to the ISO13485:2016. However, under the new structure of business strategy, few activities of the company (as such production of medical device) is taken off from main process line as few others as well.

    My question is, do the company need to revise the entire documentation of Quality manual/procedure before the upcoming survelience audit?

    Will it impact the certification to the ISO 13485:2016

    Please help to highlight your opinion on my curretn situation to corelated it with the certification of ISO 13485:2016

  • Admin verification checks and physical verification checks

    Is there any forms available for admin verification checks and physical verification checks?

  • Budgeting the EU MDR implementation

    To start with one large hospital, MDR Dept only, 28 staff in processing, what should we budget?

  • Who needs ISO?

    In Canada, we hold the licence for a viral transport medium.  We are going to hire a 3rd party contractor to actually manufacture the medical device.  Who needs ISO?  Us? The 3rd party contractor? Or both?

  • List of internal and external documents

    If we have all documents saved in an electronic folder, do we have to have the List of Internal Documents?
    What are the external documents?

  • Relation ISO, MDR and CE

    For initial research I am wondering how CE marking, Medical Devices Regulation 2017/745, ISO 14971 and ISO 13485 are related to each other?

  • Rework procedure and Clinical evaluation for media mfg

    1. Is there a rework procedure in the tool kit?  I did not see it in there and I believe it is an ISO requirement for clause 8.3.4.  Thank you.
    2. I have a question about the clinical evaluation requirement.  What exactly is needed for media manufacturer class 1 medical device?

    In looking at the documents in the toolkit it I am not sure if it applies.

    3. Also when is a CE mark required?  How do I apply for a UDI # since we don’t currently have one?

  • Is ISO 13485 required by MDR?

    This document ( states that ISO 13485 is required by the MDR? I understand that a QMS is required but the MDR does not specify ISO 13485?

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