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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2018
    510(k) was supposed to be the exception. "It's Regrettable."
    First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
    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...
    Eyal Lerner, Ph.D., B.Pharm, ICQE
    Pharmaceutical Quality Consultant [email protected]
    March 2018
    Was Theranos approved by CSM, FDA or both?
    I was not completely aware to Medicare & Medicaid Services (CMS) agency. It regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments and approve Laboratory Developed...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2013
    ISO 13485 Certification registrar and NB fees and approval time
    As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
    mahamad shafi S S
    RA
    February 2019
    How to Select a Notified Body and How to Contact
    Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
    Juan Ángel Gracia García
    Technical Director Medical Device Department
    October 2018
    Chemical peels: cosmetic, medical device, drug...or what?
    Under the European Regulation there are many cosmetic products with very low amounts of acidic components (such as glycolic acid, trichloroacetic acid, salicylic acid, lactic acid, etc).Active ingredients in higher concentrations (such as in the case...
    Jana Černá
    Regulatory Affairs - MEDKONSULT medical technology
    January 2019
    Conformity Assessment of IIa MD
    Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.Recently, I have come acros...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    September 2013
    510K VS PMA
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    March 2019
    MDR-Compliant EU Authorised Reps
    I am working to compile a list of recommended MDR compliant EU Authorised Reps for small medical device manufacturers. Any suggestions are greatly appreciated.
    Erik Vollebregt
    Partner at Axon Lawyers
    June 2016
    Transparency under the new MDR and IVDR
    With the new EU Medical Devices Regulation and IVD Regulation more or less established now, let's take a look at the transparency requirements under these regulations. This presentation was delivered at Informa's MedTech Summit in Brussels on 14 June...
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