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ISO 13485 & EU MDR - Expert Advice Community



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  • Labeling of medical device accessories

    I am looking for information on labeling of medical device accessories. Specifically, we have a handpiece to improve delivery of laser energy from the fiber to the patient tissue. The notified body (under MDD) advised us to put the same laser safety labels on the handpiece (laser class, etc) as we already have on the laser itself. I cannot find any advise like this in the standards (IEC60601-1, IEC60601-2-22, IEC60825-1)

  • Questions regarding Technical files 13485/MDR

    1: Do we need a Technical File for outsourced products that are manufactured elsewhere?

    2: Do we need a Technical File for products that we relabel?

    3: Do we need a Technical File for products that we do not adapt or manufacture ourselves but that we buy and resell (as part of one of our products)?

  • MDR article 120 significant changes

    I need your support on an issue, we changed the contact sterilization supplier of our class I sterile product.
    Is this significant change according to MDR article 120?
    I need to do a decision tree evaluation on this,
    I need information on this topic.

  • Relation of GxP to MDR in Medical Software

    What I was looking for is the relation of GxP to MDR in Medical Software, do you have anything that helps me understand the relationship better?
  • Clause 8.2.6 ISO 13485

    Hello From ISO 13485 with MDR, in 11 Production and Service Provision, is there enough in this document to cover off 8.2.6. Document 11 does not mention 8.2.6 as a reference document.  But I do not see anywhere else that does either. thanks
  • Using ISO 9001 documents for ISO 13485

    I am currently working through the ISO 13485 documentation, and have noticed that some of the documentation is similar to the ISO 9001 documentation.  If applicable, could I use some of the templates / documents that we have for ISO 9001 for ISO 13485?
  • MDR compliance for distributors

    Hello Could someone advise me as a distributor do I need my management system to be MDR compliant? I make sure all of my suppliers are MDR compliant, but I don't know if we also need to have that in our system. I did purchase the 13485 + MDR tool kit. I just read conflicting information on various sites. thanks
  • SOPs

    Thanks for the link. I downloaded the demo kit. looks good! I have few questions: I didn't see any SOP for change control. How do you cover that? Do you have SOPs for the performance, monitoring etc. of clinical trials? In the training forms I didn't see a training verification check. Do you have it implemented in the process? If so, how?
  • Does ISO 13485 cover incoming sampling inspection?

    my question is about if iso 13485 considers the sampling plan from receiving inspection and the criticality of the components? I want to check if ISO covers the incoming sampling inspection?
  • Do we need sales procedure?

    We are not yet at a stage where we know who our ‘customer’ will be. Meaning that we are designing and developing our medical devices, and are funded through shareholder investment and grants. Our plan will most likely be to license out our technology and have another company be responsible for the manufacturing of the implant aspect. Therefore, from reading the clause about sales I do not think we need a process at the moment? Our stage 1 and stage 2 audits are later this year, and nothing will change in terms of our readiness stage. Our scope is purely for the design and development of medical devices. So in this case, we do not need a sales procedure – correct?
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