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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...
    Elizabeth Doyle
    Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
    March 2018
    Biocompatible materials
    I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone point me towards such a list? Or do you have a personal list compiled over the years that I could use as a reference point? Application-wise, ri...
    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...
    Sharon Shachar
    QA Director at Medtronic (former Given Imaging)
    February 2017
    Packaging validation
    Can someone share what and how he is doing packaging and labeling validation for a non sterile product ? Quantities? Parameters ? Forms ? How many batches ? source: https://www.linkedin.com/groups/2070960/2070960-6232416918385487874
    Julie Omohundro
    Principal Consultant at Class Three, LLC
    June 2018
    Why prove the concept?
    I find working with inventors from outside the industry often raises questions that would never have occurred to me when working with an established device company. Today the question is Why prove the concept? By this I mean, what is the role of proo...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    September 2013
    I am trying to understand the trend, if there is one, away from the use of solvents in the assembly of medical devices, specifically as it is used for coating ends of PVC tube sets and catheters.
    As originally asked by
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