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ISO 13485 & EU MDR - Expert Advice Community

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  • How to handle Software/Firmware to be MDR compliant?

    I just listened to your webinar about EU MDR. It was quite rewarding as there were few surprices but still some good information. I have a more specific question regarding software. Background: We have a unit that cuts out a form in styrofoam which is then filled with a low melting point alloy. This hardend form is the put between the patient and the source of radiation to limit the radiation to certain places. The unit itself has the technical documentation made. However there are two aspects which I am uncertain how to handle: 1) Software. There is a computer software that receives input from user (from xray etc) and then converts the desired shape to be cut. 2) Firmware. The unit itself has a firmware implmented that receives the data from above software and performs the actual control of the unit. My question is: How are these two to be handled in the technical documentation? Most of the standard sections do not apply to software (Biocompatibility to name one). So.. how to handle Software / Firmware to be MDR compliant .
  • Information on Certificates such as CoC / CoA or 3.1 certifications

    I am looking for more information on supplier documentation, specifically Certificates such as CoC / CoA or 3.1 certifications I woud like to know if there is a link to the ISO 13485 requiring suppliers to send us these types of certificates.. basically following DIN EN 10204
  • Economic operator definition

    Not really sure whether I address the correct people, possibly this question came up more often. I distribute medical devices. The opportunity arises to expand our market and to deliver devices to customers of another company. We distribute the medical devices, the other company does not interfere at all with the device handling, traceability and follow-up processes (MDR obligations). They only send an invoice. Does that make them an economic operator with MDR obligations? Am I correct that if they do NOT touch the device at all with their processes (except for billing) that they will have no MDR obligations as “economic operator”?
  • Purchasing and Evaluation of Suppliers

    I was hoping you could answer a question for me, I am looking at section 10, Purchasing and Evaluation of Suppliers. I am confused with 3.3 and 3.4. Is this referring to new suppliers that we are in the process of selecting? Already approved suppliers? Or both? The reason I ask is I am unsure how you can analyse previous purchasing and shipment quality of a new supplier.
  • ISO 13485 question

    Hi- I don't think I need this but it was suggested I look into it. I make soft goods for pediatric sensors and medical devices, not the devices themselves. I'm working on a big, NIH- funded program for multiple universities so I want to be sure I have all consumer protection docs lined up. Please advise. Thank you
  • Accessories and standalone SaMD

    Could you please provide advise on the following scenario: We are currently working with a medical device class III and in order to fulfil the medical device`s intended purpose, a SaMD is developed and defined as an accessory. There is a strong architecture segregation according to a risk based approach and 62304 that ensure the SaMD to be class II based on the FDA: ...an accessory has the same class as the “parent device”, unless there are different risks for the accessory and the parent device. The accessories are then independently classified according to these risks... Is it possible to assume a similar approach will comply with the MDR regulation?   Based on this assumption: Is it possible to reuse the same accessory with other Medical Devices with different classifications, most of them class II and have its own DHF? Is it possible to develop the accessory as a standalone SaMD as an interoperable software as medical device, with interface description, interoperable specification/residual risks etc..and with its own DHF? Is this scenarion feasible in the current MDR regulation? Thank you
  • ISO 13485 Effectiveness criteria

    I attended training in Advisera and got your contact as ISO 13485 consultant and have question regarding clause 4.1.3. Here we can find, that for each quality management system process, the organization shall: determine criteria and methods needed to ensure that both the operation and control of these processes are effective. And my question is: if these criteria should be  quantitative or qualitative? and if we have Procedure for Document Control and Procedure for Control of Quality Records -  these procedures have to include effectiveness criteria?Also, for instance we have described Change Management process and effectiveness criteria for this process are: Timely notification and implementation of changes; Data analysis results. Are these ok?
  • Different between "Supplier" and "Subcontractor"

    one question regarding "10. Purchasing and Evaluation of Suppliers": What is the different between "Supplier" and "Subcontractor"?
  • MVP

    Hello,Thanks for your quick response.our commercial team produce a medical device as a startup business and we are in the MVP stage.I would like to ask you that is it necessary Iso13485 for it? So, if  "yes" how can we should apply?With thanks
  • Conciliation between Iso 13485 and EU MDR

    I want to understand all the requirements of EU MDR and their conciliation with ISO 13485 and FDA 21 CFR
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