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31st July 2018, 05:02 PM
#1
Medical Molding Audit for ISO13485 / Injection Machine Software validation
Are there any medical molders in this group? We are currently going through an audit in our Dominican Republic factory to get our Certification for ISO13485. I have worked in Medical Molding for many years producing drug delivery systems, but the auditors are now asking for Validation of the Software of the Injection Molding Machine. So my question is how do we validate the software? I have several friends that work for a very large Molding Molding Company and they tell be that they do not do any validation of the software. The auditor has told me that this is a new requirement.
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