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    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...
    Danny Kroo
    ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
    December 2018
    What are the regulatory requirements for selling first aid kits in the USA?
    Hello everyone, what are the requirements for selling first aid kits in USA?The first aid kits will include medical gloves, BZK swabs and alcohol prep pads and the suppliers of each will be FDA approved for these products.What needs to be done to get...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2018
    Yes! Crowdfunding is Working for Medical Devices!
    When UK-based EnXray, makers of the first low-energy X-ray sterilization tech, needed ÂŁ400,000 to scale its manufacturing to hit 2018 sales projections, it turned to Crowdcube. And fantastic-looking carbon-fiber wheelchair manufacturer Carbon Black i...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2019
    Device Calibration and Public Health and Safety
    Those wonderful devices you made, perfectly calibrated when customers opened the box, are still your responsibility once deployed.This guest post, courtesy of Gregg Schaeppi, Director of Client Services for PK Calibration & Validation, taught me ever...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2019
    Need a job? Distribution? Money? Do this first.
    I get asked the same questions all the time. "Joe, I am looking for a new position and/or I'm looking for new clients for my consultancy. Do you know of any opportunities for me?" "Joe, I am looking for sales representatives (1099) and/or distributor...
    Dr Kalina Tonigold
    Regulatory Affairs & Quality Management Specialist at ARRI
    October 2016
    Qualified Person (QP) in the field of medical devices
    Hi all,I was wondering what exactly a Qualified Person (QP) in the field of medical devices does and means? According to some sources which I am reading, it says “Manufacturers shall have available within their organization at least one qualified per...
    Anne T.
    Analyst and scientist for biotech investment
    December 2016
    How to file to FDA for a 510k exempt device?
    Hi all, I am looking for a simple protocol to file a 510k exempt device to FDA, since FDA provides so much detailed information of 510k and PMA on the website. I will be grateful if someone could share some simple tips of what I should do for the 510...
    Rob Packard
    Ship & Print Your FDA eCopy
    March 2017
    Is a DHF Required for a Class I Device?
    If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2015
    Know any billionaires with cancer?
    I met a molecular biologist last week at BRINK 2015 (which was excellent). He's turned his attention to oncology. I paraphrase, but he basically asked if we knew any billionaires with cancer. He wasn't being elitist. Or looking to deny service to any...
    Minoti Patel, RAC (US)
    Manager, Regulatory Affairs at Thermo Fisher Scientific
    July 2015
    Complaint Handling - Complaint or Not?
    Thoughts - A device such as ultrasound device, whose life span is 5 years. In its 6th year device does not work properly. The customer calls the manufacturer. The manufacturer offers to repair the device even though the device is outside its lifespan...
    « Previous 1 2 3 4 5 6 … 99 Next »

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