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  • What else do I need to be ISO 13485 certified when I am ISO 9001 certified?

    I am not currently ISO 13485 certified but 9001:2015 certified. What do I need to be also 13485 certified?
  • ISO 13485 for small companies

    It's regarding the standards fit into an organization with only 2 employees. We develop software for medical image management and (as it seems) need to get a 13485 compliant QMS in order to re-register our products according to MDR. The standard seems to be more geared towards larger organizations (talking a lot about management, CEO, CMO etc..)
  • Reporting of AE to FDA

    We currently have a question we are unable to find an answer to. Scenario: A box contains 200 individually wrapped products. Each individually wrapped product seems to have a loose fray that is visible to the customer. Event = "Loose fray on Product A package." One Event, One product, 200 qty. Our question is as follows: Do we report 200 individual reports, or do we report 1 report specifying that 200 products were associated with the event?
  • Deviation from requirements for batch identification

    I was wondering if you can tell me about the categorization of a finding regarding batch identification
  • Definition for critical suppliers in the context of ISO 13485

    Hi, I am trying to find a definition for a critical part (to determine critical suppliers) in the context of iso 13485.
  • CE mark and ISO 13485 for medical device in EU

    Is it necessary to be ISO 13485:2016 certified before pursuing the CE Marking? Or is having the ISO 13485 more of a benefit, and not a requirement.
  • Quality objectives or KPI in QMS Manual?

    Hi. Just wanna know if the declared procedures in our QMS Manual should always have a Quality Objectives? Or is it just okay to have a KPI for whole department? Thanks a lot.
  • What are minimum personal/roles for the new company per ISO 13485?

    What are minimum personal/roles for the new company per ISO 13485?
  • Applicable standards to comply

    If my company is working on providing services (etc lab imaging services), which standard should we be certified on ? Do we still need ISO 13485?
  • Product Realization requirements for distribution and manufacturing facility

    I am currently doing an ISO 13485 system for the first time. I have several years of experience in ISO 9001 and EHS but need help in 13485 please.
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