Medical Devices Group

    Question
    July 2019
    Leonard Eisner
    EU MDR 2017/745 – Are You Ready for Big Changes?
    Article link below, quick summary of article: Why the regulation was needed, the changes and impacts, NB designations and Brexit updates, and steps to implement this huge change. See: EU MDR 2017/745 – Are You Ready for Big Changes?
    July 2019
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    The time-buying MDR trick you need to hear immediately
    I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here's that 9-minute conversation. Get or renew your CE mark TODAY! If you prefer reading, the conversation highlights are: Get or re...
    March 2017
    Arthur Brandwood
    Medical devices and IVD regulatory expert with a global perspective
    EU MDR - are the tables turned with FDA?
    Looking through the Final text of the EU MDR, it's obvious that although the familiar rules based classifications, risk based review and 3rd party conformity assessment remain, there's a whole lot of New and the bar is raised much higher. There are m...
    January 2017
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    New Medical Device Regulation (EU)
    As originally asked by Dan O'Leary President at Ombu Enterprises, LLC The General Safety and Performance Requirements do not mention any specific harmonized standards. However, there are QMS and RMS requirements in various parts of the EU-MDR. No dou...
    August 2016
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    EU special registrations before marketing a device
    Does anybody have a list of European countries Competent Authorities / Ministry of Health that require further communication/declaration/registration once the CE-mark obtained? Thank you for you help!source: https://www.linkedin.com/groups/2070960/20...
    July 2016
    Divya G.
    CEO and Founder at Regulatory1
    Can we consider Israel representative as a part of EU representative for CE marking ?
    EU representative for CE marking: is Israel consider an European address in your point of view?source: https://www.linkedin.com/groups/78665/78665-6161602791837044737
    January 2015
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    EC-REP change of address - what are the challenges?
    A question from group member Mike Murphy QA Consultant, Combination Product Launch at The Medicines Company: Can anyone share experience of change EC-REP address (within the same country or otherwise)? How much time do NCA's allow to remediate IFU's ...