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ISO 13485 & EU MDR - Expert Advice Community



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  • 4.2.4 and 4.2.5

    I had one question. What does this verse mean exactly for 4.2.4 and 4.2.5 on ISO 13485? The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.
  • ISO 13485 toolkit ref 11

    I wonder if you can give me some guidance on ISO 13485 toolkit ref 11 procedure for production and service provision. As we are a distributor the only part I seem able to answer on here is 3.3.7, because I can relate that to the batch and serial tracking once we have received the goods through to their delivery at customer. I know the QMS says various parts of 7.5 can be excluded. But I am not sure if need to fill in more in order to be complaint?
  • MDR requirements for IFU

    a small question, may you help me: I searched all and didn't find: are there sume restrictions or requirements regarding font size used for IFU?
  • Diferent references for manufacturer and distributor

    Hello, As a local distributor I'm buying MD Calls IIa to a International Distributor. The Manufacturer presents a Product Code X, but the International Distributor present us a diferente Order Code Y. Is this compliant with the new MDR? In my country MD Regulator, the product is registered with the manufacturer code. Which code should I register im my ERP? Thank you, Isabel Sottomayor  
  • 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.
  • 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: 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?
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