Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium

Community

Start a Discussion
    • Newest
    • Most views
    Question
    Aditya Singh
    June 2019
    How complex are medical device testing services?
    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 🔥
    April 2019
    Device Calibration and Public Health and Safety
    Those wonderful devices you made, perfectly calibrated when customers opened the box, are still your responsibility once deployed.This guest post, courtesy of Gregg Schaeppi, Director of Client Services for PK Calibration & Validation, taught me ever...
    James Davis
    Head of Quality and Regulatory Affairs
    March 2019
    Safety and Performance Based Pathway - FDA
    Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    March 2019
    Why Are Productive University Partnerships So Hard?
    You have a milestone. To achieve it, you need research… so you search. In-house? Crazy talk. Contract Research Organization? Your budget is too small.The University down the road? Now we're talking, you think. They have smart people, cutting-edge equ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    March 2019
    To notify FDA or not, that is the question
    Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. • You notify the FDA (and if you do, how?); or, • You don't notif...
    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.
    Walter Maclay
    | President, Electronics, Software Design | Expert Speaker in Wearables, Wireless, Medical Devices, Consumer Products |
    February 2019
    Can a toilet be a medical device?
    We are starting to see smart toilets enter the market or get close to entering the market. They include sensors such as electrocardiogram, body temperature, and photoplethysmogram to measure blood oxygen level.What do you think? Is it a medical devic...
    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?"
    Danny Kroo
    ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
    January 2019
    Private label process for FDA
    A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance and the only product change will be the company's name on the label. There will be no change for the i...
    « Previous 1 2 3 4 … 26 Next »

      Stay connected with us.

      By signing up you are agreeing to our Privacy Policy.

      Categories

      • Capital/Investment
        • Business Model
        • Funding
      • Careers
      • Design/Devel
        • Design
        • Development
        • Human Factors
        • Labeling
        • Material Selection
        • R&D
        • Trials and Post-Market
      • Featured
      • Industry
        • Announcements
        • Device Tax
        • Hospital and Health Care
        • Innovation
        • Medtech
      • LinkedIn, etc.
      • Markets
        • Africa
        • Americas
        • Asia
        • Australia
        • Europe
      • Regulating
        • CE Marking
        • EU
        • FDA
        • FDA/EU etc.
        • Notified Bodies
        • Quality
        • Regulatory
      • Selling
        • Distribution
        • Intellectual Property
        • Marketing/Sales
        • Reimbursement
      • Worth bookmarking!
      Featured Job

      You Won’t Want to Miss a Thing.

      We’re working to make MedicalDevicesGroup.net the world’s most useful site to serve the medical device industry.

      By signing up you are agreeing to our Privacy Policy.

      logo

      Companion to LinkedIn's 350,000 member community

      • Contact
      • Medical Device Marketing
      • In Memoriam
      • Medical Device Conference

      The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

      The 10x Medical Device Conference

      – May 10-12, 2022, San Diego, CA

      See Agenda

      Medical Devices Group
      Powered by  GDPR Cookie Compliance
      Privacy Overview

      This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

      Strictly Necessary Cookies

      Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

      If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.