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ISO 13485 & EU MDR - Expert Advice Community



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  • 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.
  • Applicable ISO Standards for Sterilization

    Dear Sir, I work as an engineer in a research laboratory for SGS. I am contacting you because we are currently running a project about microwave sterilization. Can you please help me finding a way to have access to all ISO norms about microwave sterilization or sterilization in general? Are they available online?
  • QMS set up for manufacture of medical device

  • Compliance with ISO 13485 or GMP for Class III device

    Hello, There is a requirement for planning the plant for medical device class 3 production(dermal filler) another than ISO 13845? The plant will be under demand of ISO 13845 or under GMP demand? In Europe.
  • Submission of Non-conformity Report

    I work at a company here in Brasil.We are ISO 13485 certified and I would like to know where do we have to send the nonconformities report. It is written that the Recipient must be the National Competent Authority (NCA).
  • Complaint Handling in ISO 13485

    Hi, looking at your page regarding complaint handling for ISO13485:2016 but the article didn't state what section it was in? In 2003 it was part of 8.5.1 but there is no talk of complaints in 8.5.1 in the 2016 standard.
  • Medical Device File

    I never did ISO 13485: 2016 before and I would like to know what kind of Medical device file format. Could you pls. give me some example format.
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