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  • Obtaining CE Mark

    Can a product owner who does not own ISO13485 but manufacturer has its ISO13485 apply and obtain CE marking for medical device product"

  • Importer and Distributor obligations under MDR

    We will be working with importers / distributors for our product. Possibly we will be importer or distributor ourselves for some products in future.

    When checking MDR obligations for economic operators they should (amongst other obligations) perform a verification of medical devices they handle.

    I have clear what needs to be documented for the verification but what I do not have clear is whether this verification obligation applies

    • to devices that ere CE-marked under MDD and MDR or
    • to devices that are CE marked under MDR only 

    I highly appreciate your help, best regards,

  • Understanding requirements for company providing technical services

    Need to understand the requirements for a company providing technical services, including technical writing, for a medical device company.

  • Which clause should I refer for supplier qualification?

    Can I know which clause should I refer for supplier qualification?
    for ISO 13485: 2016 - Is it 7.4.2 (c)?

  • Sub clause Explanation

    1. In which clause does the recording of FPA approval , Daily check sheets, Recording of clean room temperature comes under?? 2. Under which clause does the naming (Document number , Rev no , Date ) for a format comes ??

  • Clauses that require records

    Regarding al the ISO 13485 clauses:
    -Which ones are the ones that require records? 

  • Checklist for pre-/post site inspections

    We are moving our cold storage (medical diagnostic kits and reagents) from one site TNT to a new site Fedex.

    Do you have a checklist or can you give me tips on what to put in my checklist for the pre-/post site inspections before and after the move?

  • Non-applicable clauses for supplier of component for medical device

    As a supplier of component for medical device, which clauses will be not applicable for us?

  • Differences between medical device certifications and ISO 13485

    What are the main differences between medical device certifications and ISO13485?

  • Procedure for the Software Life Cycle

    I have vigorously started to implement the QMS in our company. I see that you do not have a separate procedure for the Software Life Cycle… Don’t you guys have such a template?
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