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ISO 13485 & EU MDR - Expert Advice Community

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  • 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.

  • 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

    Hi,

  • 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).
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