ISO 13485 & EU MDR - Expert Advice Community

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  • Single Registration Number for MDR

    What is considered a Single Registration Number for MDR? How do you acquire it? I have a UDI for each product and Device Nomenclature Codes(GMDN)
  • Design and Development Agreement

    Do you have a template for "Design and Development Agreement". I mean for outsourced process?
  • Design and Development Agreement

    Do you have a template for "Design and Development Agreement". I mean for outsourced process?
  • Gaps From MDR to CFR

    What are the Gaps From MDR (SaMD) to also comply with US FDA regulations CFR (21)?
  • Risk-based approach

    We are doing our first ISO 13485 certification now. Our auditor want to have "Risk-based approach" for some of our processes. Can you provide me some example here? Our auditor say they can be as an unique standard table which we integrate it use in different processes. Do you have any idea here?
  • MDR vs CFR 21

     “Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”  

    Gap analysis MDR vs CFR 21 

  • Direct part marking for reusable devices class I

    I have a question regarding direct part marking for reusable devices class I
    Is it a label or can it be a serigraphy?

  • Rodent and Pest Control Program for Medical Device Manufacturing

    Does ISO 13485 or some other FDA regulation require Rodent/Pest Control programs for Medical Device manufacturers similar to those required for GFSI Food Safety food contact manufacturers?
  • Question on Monitoring and measurement of product

    I have a question about section 8.2.6 of ISO 13485, concerning the following: “As appropriate, records shall identify the test equipment used to perform measurement activities.” Exactly how far do we have to satisfy this requirement? Right now all our measuring equipment is listed in our ERP database along with calibration information. But do we have to identify the exact tool used each time a measurement is made on a part? I’m asking as our ERP system doesn’t go into that level of detail: I can list what type of tool to use, but not actually the tool ID used specifically for each measurement.
  • What rules should be applied to 3D printed - patient specific products?

    What rules should be applied to 3D printed - patient specific products (we understand that 3D product is not under custom made according to MDR, should be CE marked - but labeling should contain patient data as custom made product). This is not serial or custom, is in the middle - patient specific - missing term and conditions in MDR. We have to put CE on our products and DoC (we declare conformity of the process) - but finally the clinician should provide declaration based on individual paient´s data?
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