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    Question
    John Sanchez
    COO at Mount Mfg
    July 2015
    FDA Audits
    How common are random FDA audits for device manufacturers? Does the FDA focus mainly on class 3 device companies? Do they ever randomly audit contract manufacturers? Can anyone share any insight into this topic for me? As always I appreciate your com...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2015
    FDA answers cybersecurity questions
    "Cybersecurity isn’t just a design issue. It’s not just at product launch. It’s a life cycle issue. It requires a change in mindset." So said FDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasur...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    May 2015
    How to Prepare a 510(k) Submission for the FDA
    Long-time readers won't be surprised that 13485-expert Robert Packard's workshop at the 10x Conference was standing room only. Or that he offered to teach his class for free. Register at http://medgroup.biz/510k-tips for Rob's free workshop on how to...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2015
    12 Steps for UDI Submissions to the FDA GUDID
    UDI regulations kick in for Class I and II devices in 2015. So let's start the year with a free webinar for ways to make your UDI submissions easier. http://medgroup.biz/UDI-in-2015 Reed Tech is my go-to on this subject. They'll cover: • Requirements...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2014
    FDA Said No
    19 months ago we featured group member Mark DuVal's Citizen Petition and Petition for Stay of Action with the FDA. Read that discussion: http://bit.ly/FDA_petition The petition challenged FDA's practices and interpretations for reviewing 510(k)s and ...
    Gary Price
    Executive Business Coach & Sales Leader
    March 2014
    Marketing and FDA
    I work for a class II medical device manufacturer that has never done anytime of marketing. My job is to get us into the 21st century with aligning us with the way buyers want to educate themselves and buy - which is digital marketing strategies. How...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    October 2013
    Challenges of the FDA 510(k) process
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2013
    For software that falls under the medical device category, does coding have to follow a specific guideline or standard to be FDA compliant?
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2013
    Does anybody have good advise or good articles about getting medical devices approved by FDA or similar in other countries?
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2013
    When the FDA medical device approval process goes wrong
    Surgeon's Criticism of FDA Echoed in Senator's Book It's the situation we all dread: A device with an obvious market and strong evidence of effectiveness bogs down in a seemingly endless FDA approval process. According to Colorado surgeon Dr. Robert ...
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