ISO 13485 & EU MDR - Expert Advice Community

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  • 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?
  • Design and development of a service

    If the company offers facilities and equipment for hire, would tht class as the service and would each new customers requirements need a new design and development?
  • Swiss Notified Bodies

    Hello Sorry if this is in the wrong category. My Swiss supplier uses a Swiss notifed body for their ISO and CE.  I beleive Swiss notified bodies are no longer accepted in the EU.  The same applies in the UK from what I have been told. When I asked my supplier, they said comapnies in Europe are still purchasing from them. I do not dount they are telling me the truth.  But this cannot be correct as it is not MDR compliant is it? So I would be correct to stop selling the product? Thanks
  • Is ISO 13485:2016 Quality Manual Template compliant with MDR?

    We(a U.S company) implemented and certified ISO 13485:2016 using Advisera's template package last year. I could never understand the "_EN"  at the end of the Procedure titles. We are now working with an NB to certify a class IIa product for MDR and MDSAP to sell outside the U.S. I now think I understand the " _EN". Prior to the audit our NB wants me to verify / confirm whether our Quality Manual meets the requirements of EN ISO 13485:2016 as well as MDR. Can you confirm this? The only gap I see is that Post Market Surveillance is not mentioned in the Quality Manual but I'm not sure it is a requirement for the Quality Manual.
  • Accessories to Medical Device

    We are class II manufacturers, and our device contains stimulator, its charger and charging cable. Can we call the charger and the cable as accessories or it is part of the stimulator? We don't intend to sell the charger and the cable separately except for replacement as spare parts. On the same context, we also have electrodes which is connected to the stimulator with a cable. The main intended use of the device cannot be achieved without the electrodes and cable. In this scenario can we call the elecetrodes and cable as an accessory to our device? We intend to sell the electrodes and cable each separately. I know if we are planning to sell the device separately, each need to undergo its own conformity assessment but the confusion is whether to declare it as accessory or not?  Thanks for the response.
  • ISO 13485 Certification in company without manufacturing processes

    I would like to ask you about ISO 13485 certification. Is it possible to certify a company that will outsource the production of devices? I am referring to the following business model as follows. Company A implements and certifies the ISO 13485 system and outsources all production and quality control to its subcontractor company B, which has ISO 9001. Can the company A certify itself in such a case, or if it does not have production (manufacturing) processes will the certification company not be able to carry out ISO 13485 certification audits?
  • CE mark

    For the purpose of the CE mark, our consultant prepared a post marketing surveillance (PMS) document and said that I should have (as part of the 13485) a procedure for how to prepare such a document. According to the post marketing surveillance document that our consultant prepared, I see that parts of this documents is based on procedures that are listed in different documents that you have provided (e.g., 08_Customer_Complaints_and_Feedback, 16_Adverse_Event_Investigation, and 15_Nonconformities). I wonder if you have a single document that describes the procedures for a PMS review.
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