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    Marco Viceconti
    December 2019
    Is your company considering In Silico Trials in the next 36 months?
    Medical devices companies use modelling and simulation in the design phase but it's now possible in principle to produce evidences of safety and/or efficacy using computer models, something called In Silico Trials.FDA has produced guidelines, and the...
    Ann Angel
    August 2019
    Service and repair under UDI requirements
    I use a FDA and CE registered sub-contract manufacturer for a FDA and CE registered Class 2a hand-held device., which my company sells around the world (in small numbers). We have implemented the UDI requirements. All fine. The issue comes when the m...
    Szymon Krzemiński
    August 2019
    Private Label Requirements, Manufacturer's Registration & Initial Importers
    A single-member LLC with a non-US alien owner wants to sell Class I, 510(k)-exempt medical device via Amazon FBA. The manufacturer of the device is a foreign business entity and has a valid FDA registration. The LLC wants to sell the medical device a...
    mahamad shafi S S
    RA
    August 2019
    Is there any specific time line to update the labels for the *Class* *I* and *Ir* devices.
    Is there any specific time line to update the labels including the UDI/human readable requirements for the *Class* *I* and *Ir* devices.
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2019
    That Time Draft Guidance Screwed Up A Submission
    I frustrated regulatory expert Michelle Lott because, despite us having discussed it many times, I still couldn't grasp how draft documentation can screw up FDA submissions. Bless her Southern heart, she persevered. We recorded the call and you can u...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    May 2019
    Please Tell Me You Did NOT Say That to the Auditor
    Guest author Mark Proulx has seen a lot of head-shaking choices from prospective clients. I say "prospective" because, after conversations like the one below, he stayed clear of their impending disaster. Do yourself a favor: Don't say this to your au...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    November 2017
    How to avoid the worst CAPA system implementation pitfalls
    Even though the Corrective and Preventive Action (CAPA) process is at the heart of any quality management system, CAPA violations are the most frequently observed Quality System subsystem cited by FDA. It happens year after year – and regardless of t...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    May 2017
    Managing Changing Standards in Multiple Jurisdictions
    Organizations today are faced with a growing list of new and changing standards, and keeping pace with them has become increasingly difficult. It’s hard enough to manage regulations in one country, much less multiple countries. How are the most effic...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    May 2017
    Why Your Data Needs to be in the GDSN (Global Data Synchronization Network)
    Government agencies in the US, UK, EU and elsewhere now are mandating electronic product data submissions. And major customers including Group Purchasing Organizations and hospital networks need access to the data in a standard format. That’s where t...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2013
    Device Manuals
    As originally asked by
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