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ISO 13485 & EU MDR - Expert Advice Community



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  • 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?
  • 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
  • Clean room criteria for ISO 13485

    I have a 20 x 30 glass walled clean room sitting in a create for some time now and have decided to erect it so we can finally start working at an ISO 13485 situation. I would like to know for now only clean room criteria for iso 1 (class A) and based on that, I would like to know costs to retain you or cost to provide a cert jhow to go about getting an inspection etc
  • Question about notify body

    I am putting an ISO 13485 QMS system.  I have previously had 2 QMS systems in other companies accredited by notified bodies and thought that this is the only way to gain certification. My present line Manager states other companies other than notified bodies can issue ISO 13485 instead of going down the notified body route, I am not sure that this is right. I cannot find a company that does this. Am I right in thinking it has to be a notified body
  • What sections of ISO 13485 cover computer systems?

    Would like to know what sections of ISO-13485 cover computer systems or is it another standard?
  • Auditing according to section 8.2.2

    I've been asked to conduct a 13485 audit specific to complaint handling. Would I only need to audit according to section 8.2.2? Thank you!
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