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    Question
    Greg Accetturo
    August 2019
    What is the best resource for finding medical device distribution partners?
    It appears this topic was covered in this forum back in 2012 and the HIDA conference was suggested as a possible resource. I've heard both positive and negative experiences concerning finding medical device distribution partners at HIDA and was hopin...
    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...
    Avital Arbel
    QA consultant at Avital Arbel QA services
    October 2017
    notified bodies accredited to ISO 13485:2016
    Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2016
    Independent reviewer in Design Reviews
    An independent reviewer is required for Design Reviewes. The problem in small start-up companies is that everyone is involved in the process and no one is really independent, on the other hand an external consultant may be very expensive for those co...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2018
    510(k) was supposed to be the exception. "It's Regrettable."
    First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
    Rob Packard
    Ship & Print Your FDA eCopy
    October 2016
    10 Things to include in a sterilization validation protocol
    I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:1. Make sure you specify the revision of all standards referenced and make sure the version is...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2016
    Re-sterilization of medical devices
    Hello everyone,First, thank you for accepting me in your group.Can sterile medical devices be re-sterilized and used as new and according to standards/lows if they expired (as a product) but haven't been used? Re-packaging is also required?Thank you....
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    February 2018
    How my dog died on Saturday
    Our beloved King Charles Cavalier, the first pet I've ever had, died on Saturday. It hit me harder than I thought it would. Named after my hometown, 11-year-old "Brooklyn" had a biopsy on Friday. We learned he had cancer of the mouth. We decided as a...
    Zeljko Roncevic
    M.D., Ph.D. Pediatric Cardiologist, Professor of Pediatrics
    July 2012
    The role of physicians in the medical devices industry?
    Why I ask this? As a physician sometimes I have a feeling that in this group I'm not at home because it's mainly a group of businessmen, salesmen, distributors, engineers and others outside health practice with quite another way of thinking. Many of ...
    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...
    « Previous 1 2 3 4 5 … 99 Next »

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