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    Joe Hage
    đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
    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.
    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?"
    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...
    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...
    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...
    Joe Hage
    đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
    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 ...
    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...
    Ales Martinovsky
    Endeavor, optimism and joy of life among great people
    February 2017
    Are CLINICAL DATA valid if not obtained according to local legislation?
    The real case is: A medical device is already long time on EU market and serving well to patients. Post market clinical follow-up have been performed and it delivered a lot of new clinical evidence which has been used in technical file of the medical...
    Daniel Schwartz
    Associate Director of Marketing at Morningside Translations
    February 2017
    FDA to collaborate with IBM's Watson
    The FDA has announced a plan to work with IBM and their AI program Watson to develop new ways to exchange health data across a variety of different platforms. Medical Device Daily has more:http://www.medicaldevicedaily.com/servlet/com.accumedia.web.D...
    Julie Omohundro
    Principal Consultant at Class Three, LLC
    August 2016
    Direct to De novo – two years after release of the draft guidance
    It's been two years since FDA published its draft “direct to De novo” guidance, on August 14, 2014. Although many of the classification requests that have been submitted since that date are still under review, this seems like a good time to take a pr...
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