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ISO 13485 & EU MDR - Expert Advice Community

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  • Multiple scope in one certification

    Our company is certified for meeting ISO 13485 requirements for the scope of design, development, manuafcture and sales of product for brand A. Our Parent company has requested to get certified for their brand (i.e Brand B) with the scope of manufacture aand sales of products. Would this be treated as a spearate certification and would require both stages of audits? or can be integrated with existing one as an extension of scope

  • Repackaging of a medical device

    The company, which is a distributor of medical devices but not an authorised representative, plans to purchase medical devices in various EU countries and supply them repackaged to other EU countries. The repackaging operations would be as follows: replace the outer packaging (box), stick a new label on the container and adding instructions for use. The package, sticker and instructions would be in the language of the country to which the medical device is to be supplied.  The integrity of the inner container would not be compromised. Do I understand correctly that according to the requirements Article 16 of MDR, such a distributor would have to apply to a Notified Body to have its quality management system assessed by NB?

  • Contract Review Scope

    What is the scope of contract review?  What triggers a contract review?  We are currently reviewing all POs regardless whether they are for existing parts or for new parts.  It seems like overkill and basically contract review has become a production planning process rather than a contract review process.  The focus is purely on do we have the material and capacity to meet the customers due date. By doing this this, we miss a thorough review of new part requirements because we are overloaded with existing part contract reviews that need to be quickly.

  • MDR Deadline

    We are a Class I and Ir dental hand instrument Manufacturer, Repackage and relabeled. We have never been certified to EU MDD or EUMDR. When is our deadline to get a Notifying body to accept us and to complete our MDR certification?

  • Identifying gaps between ISO 13485 and ISO 9001

    We are currently ISO 13485 certified. We would like to become ISO 9001 certified. Do you have anything that will help me identify the gaps that we need to fill?

  • Becoming third-party certification body

    If our company would like to become a third-party certification body, how do we go about this, where do we register and what processes need to be done. We are already writing SOP’s and QMS for device companies,  how can we get to become auditors and where do we register as such.

     

  • Risk Management

    Our company has no prior risk management documents on any devices to prepare the risk management packages. I was thinking if I can help engineers by having some samples of similar devices to ours? What is your thought on it?

  • Regulatory Compliance QMS Program

    Please provide a regulatory compliance QMS program specifics contents laid out in a document which is required for a high risk complex class III medical device PMA approval for US FDA and European countries.

  • Definition of a non-conformity

    Looking for a clear definition of non-conformance. Specifically related to medical device. Would you be able to provide a clear definition of a Major and a MInor non-conformance? I have looked at the ISO standards, as well as the FDA 21 CFR guidance. I am not seeing a clear definition for these two terms.
    Please advise

  • Risk/ Supplier - what happens if a supplier ceases trading.

    Hi I wonder if i could have some advice. 

    I am just working on updating my purchasing and supplier evaluation and risk assessments.  I am not sure what category this issue comes in, possibly both.  But the question is, if a medical device manufacturer goes bankrupt or ceases trading for whatver reason, and we hold product which we are looking to sell as a distributor, can we sell this? I am concious that there is no manufacturer support for the product if they are no longer around.   No post market surveillance would be able to be conducted.

    Thanks, Chris 

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