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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2015
    Country of Origin Labelling – Medical Devices
    Consider the following: device OEM is in Germany, contract sterilisation is done in the UK, the OBL owner (and therefore Legal Manufacturer) is also in the UK. For labeling in the US market, which is the correct country of origin: Germany or the UK?s...
    Luisa Mella
    Strumenti medicali
    November 2015
    Use of RUO and IUO labeling
    Dear all, I have a question about RUO and IUO labeling in US market.According to FDA guidance "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only": RUO product is an IVD product that is in the labor...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2016
    ISO 14971:2016 and Labeling
    As originally asked by Erin Seiler, MBA Account Manager, Color & Additives North America at PolyOne A huge trend in labeling we are seeing on the manufacturing end, is a change from stickers or other forms of identification to laser marking technolog...
    Whitney Lewis
    Quality Assurance Specialist at Blackrock Microsystems
    November 2018
    How to determine when to label a medical device as investigational use only
    Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    March 2019
    MDR labelling requirements -UDI
    As originally asked by
    Luisa Mella
    Strumenti medicali
    February 2016
    Use of IVD symbol on labeling in USA
    Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate "a medical device that is intended to be used as an in vitro diagnos...
    Patrick Baranczak
    Responsable Production chez Sonoscanner
    December 2016
    UDI label creation software
    I am using Avery labels on a A4 sheet and a desktop laser printer. Can anyone suggest me software to create labels with a bar code type GS1-128 Datamatrix? I found the software "Nice label pro" that would suit me, is there any other on the market? Th...
    Anthony Molliex
    Quality and Regulatory Affairs Director chez Arthesys S.A.
    October 2016
    End of Own Brand Labelling (OBL) procedure ?
    I would like to know if some of you have issues with this procedure ? What is your Notified Body and does it still accept OBL procedure for CE marking ? I think that is a huge concern for many Medical Device companies and it deserves a discussion. so...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2016
    Hi just curious, what type of label printer do medical device industry usually use to print labels efficiently ? Thanks
    source: https://www.linkedin.com/groups/78665/78665-6211618860588761089
    Steve Bixby
    Director, International Sales & Marketing at MorTan, Inc.
    February 2016
    What are the FDA labeling requirements for disposal of a medical device?
    Is anyone aware of the FDA guidance documents to say what medical devices require specialized instructions for disposal? I’m not talking about ones with obvious hazards such as implantables or ones with sharps, but simple Class I single-use devices. ...
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