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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    September 2015
    Launching without FDA clearance
    *This is not professional advice.* In fact, it's borderline irresponsible, but here goes. So I was talking to this guy who found me from the group. To protect his anonymity, I'll be vague about his selling proposition. He told me he's building an app...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    October 2018
    New FDA Guidelines: Do you know all 10 of these?
    I've been hosting 10x Medical Device Conferences for six years but no one – before Bob Marshall – sang on stage. You likely recognize Bob's name if you subscribe to his extremely popular Med Device Online site where he serves as Editor in Chief. I ci...
    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...
    James Davis
    Head of Quality and Regulatory Affairs
    March 2019
    Safety and Performance Based Pathway - FDA
    Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
    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 🔥
    January 2018
    How to Prepare for an FDA Pre-Submission
    To ring in the new year, https://medgroup.biz/pre510k. This is a three-hour replay and the 108 slides from David Amor and Jon Speer's presentation at last year's 10x Medical Device Conference. We're making them available this week for $59 (guests pai...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2017
    What is the FDA Mandate?
    In his insightful 10x Conference talk at http://medgroup.biz/Gulfo, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketi...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2018
    How big a deal is FDA's Case for Quality?
    From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you learned about FDA’s shift their from 'compliance with regulations' to 'device quality.' Get the replay and register for part two at https://medg...
    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 🔥
    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
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