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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2018
    FDA's Case for Quality: What, Why, and How?
    Ooh, I've got a good one for you today: An FDA regulator is giving a special 90-minute webinar for Greenlight Guru and the Medical Devices Group. Shout out to Jon Speer for arranging. Your free registration at https://medgroup.biz/case-quality. Franc...
    Bradley Merrill Thompson, RAC
    Medical Device, Digital Health and Combination Product Regulatory Attorney
    June 2018
    FDA Precert program lacks legal authority
    FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the age...
    Mark Proulx, CQA, cSSBB
    Quality and Remediation Rock Star
    September 2016
    Recall Correspondence to the FDA
    Does anyone have examples of investigations about medical device recalls that they could share that was something upper management actually LIKED? I swear this is about the most political aspect of the medical device industry I've found and I really ...
    Richard Bollinger
    Founder and CEO of Menlo Park Associates and Menlo Park Software
    November 2017
    FDA compliance crisis still a threat.
    New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections still get CAPAs that are voluntary or official actions. This holds true going back to 2009. See the chart below. Note the black line that holds steady as th...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    October 2016
    How to Save Costs on Your 510(k) or PMA
    Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It's 80% for PMA devices. "A lot of that cost is due to how poorly we handle data," explained Jim Rogers, President of Nextrials, at the...
    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 🔥
    May 2016
    We Must Challenge FDA
    Veteran device CEO Joseph Gulfo says, "The FDA must be challenged (when appropriate) because it operates in a highly political environment and has strayed from its original mandate." His full 2016 10x Medical Device Conference talk, slides, and trans...
    Rob Packard
    Ship & Print Your FDA eCopy
    September 2016
    If you send this form to the FDA you can save $2,345 on your next 510(k).
    The FDA actually reduced their fees this year, effective October 1, but the FDA offers fee reductions for small businesses too. Most of my clients qualify, but very few of these small businesses take advantage of the FDA fee reduction. Small business...
    Arthur Brandwood
    Medical devices and IVD regulatory expert with a global perspective
    June 2016
    FDA's updated biocompatibility guidance is here
    FDA's New Biocompatibility Guidance is here. It's a detailed, lengthy guidance, with a strong emphasis on risk management grounded in a thorough knowledge of device materials toxicology. This is a very different guidance from the old G95-1. FDA Bioco...
    Rob Packard
    Ship & Print Your FDA eCopy
    September 2017
    Spike in FDA user fees for FY 2018 and what to do about it
    The release of the FY 2018 FDA user fee schedule was delayed until the end of August, because the re-authorization of user fees was not approved until August 18, 2017. For PMA submissions and related supplements there is a 33% increase. For 510(k) su...
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