Medical Devices Group

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

Community

Start a Discussion
    « Back to Full Questions List
    • Newest
    • Most views
    Question
    Sabrina Dessources
    Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
    August 2015
    ISO standards versus EN ISO standards
    Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
    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 ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2016
    ISO 14971:2016 and Labeling
    As originally asked by Erin Seiler, MBA Account Manager, Color & Additives North America at PolyOne A huge trend in labeling we are seeing on the manufacturing end, is a change from stickers or other forms of identification to laser marking technolog...
    Avital Arbel
    QA consultant at Avital Arbel QA services
    October 2017
    notified bodies accredited to ISO 13485:2016
    Hi all. does anybody know how one can find out which NBs have already been accredited? I know BSI have, they naturally boasted being the first ones. but is there some list or do I have to screen the NANDO? source: https://www.linkedin.com/groups/2070...
    Rob Packard
    Ship & Print Your FDA eCopy
    October 2016
    10 Things to include in a sterilization validation protocol
    I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:1. Make sure you specify the revision of all standards referenced and make sure the version is...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2016
    Independent reviewer in Design Reviews
    An independent reviewer is required for Design Reviewes. The problem in small start-up companies is that everyone is involved in the process and no one is really independent, on the other hand an external consultant may be very expensive for those co...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    February 2018
    How my dog died on Saturday
    Our beloved King Charles Cavalier, the first pet I've ever had, died on Saturday. It hit me harder than I thought it would. Named after my hometown, 11-year-old "Brooklyn" had a biopsy on Friday. We learned he had cancer of the mouth. We decided as a...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2016
    Re-sterilization of medical devices
    Hello everyone,First, thank you for accepting me in your group.Can sterile medical devices be re-sterilized and used as new and according to standards/lows if they expired (as a product) but haven't been used? Re-packaging is also required?Thank you....
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2018
    Yes! Crowdfunding is Working for Medical Devices!
    When UK-based EnXray, makers of the first low-energy X-ray sterilization tech, needed £400,000 to scale its manufacturing to hit 2018 sales projections, it turned to Crowdcube. And fantastic-looking carbon-fiber wheelchair manufacturer Carbon Black i...
    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...
    « Previous 1 2 3 4 5 … 99 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

      - 15 September 2022, Center London

      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.