Medical Devices Group

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

Community

Start a Discussion
    « Back to Full Questions List
    • Newest
    • Most views
    Question
    Richard Alberti
    Chief Operating Officer at Medpoint, LLC
    August 2017
    Outsourcing complaint handling and post market surveillance
    Does anyone have first hand experience or recommendations for a 3rd party outsourced provider for turnkey management of medical device complaint handling and postmarket surveillance services?source: https://www.linkedin.com/groups/2070960/2070960-630...
    Erik Vollebregt
    Partner at Axon Lawyers
    July 2017
    New legal obligations and liability under MDR and IVDR
    My presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDRNew legal obligations and...
    Rob Packard
    Ship & Print Your FDA eCopy
    June 2017
    What is “Level of Concern” (LOC)? And Why does it matter?
    There are 11 different types of software validation documents that the FDA requires. One of the documents is a rationale for the "Level of Concern." Level of Concern (LOC) is a term that the FDA uses to categorize the risk of software as a medical de...
    Rob Packard
    Ship & Print Your FDA eCopy
    May 2017
    How to write an adverse event reporting procedure
    There a huge increase lately by quality managers in the topic of adverse event reporting. This is partly because the new requirements in ISO 13485:2016, Clause 8.2.3 for reporting to regulatory authorities. In addition, the publication of the new Eur...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    May 2017
    Validating security patches
    I would like to check what is in your experience the best way to make sure that security patches installed by a hospital on your device are validated prior to installment? or in other words, what is the best way to ensure hospitals contact you when i...
    Jenny Osberg
    Quality Assurance Manager at Entellus Medical, now a part of Stryker
    May 2017
    Receiving Acceptance Activities (820.80 and 13485:2016-7.4.) advice needed
    I want to ensure we maintain conformance to 820.80 and also incorporate the risk-based approach to acceptance activities. We are looking for potential opportunities to reduce or eliminate inspections based on the item such as supplies vs raw material...
    Rob Packard
    Ship & Print Your FDA eCopy
    April 2017
    Recent Trends in 510(k) Deficiency Letters
    Three different clients of mine have recently received 510(k) deficiency letters from the FDA related to human factors. I have heard similar feedback from colleagues that specialize in FDA submissions. The FDA guidance document has not changed since ...
    Hyemi Shin (신혜미,차장)
    Principal Quality Systems Specialist at Medtronic Korea
    April 2017
    DHF requirenents for design changes
    Hello, i'm working in spinal implant manufacturing company. DHF formalises input, output, verification, validation, review and transfer. After post production we continue to create revised DHF for design changes. Our DHF is system based e.g. Cervical...
    Rob Packard
    Ship & Print Your FDA eCopy
    April 2017
    IFU Validation and Post-Market Surveillance
    Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, your company and they are highly skilled in the specific procedures your device will be used ...
    Julia P.
    QA Team Leader at Blatchford
    March 2017
    ISO 13485 vs Both ISO 9001 and ISO 13485
    It has now been some time since the release of the updates ISO 9001 and ISO 13485. There was some discussion in this group about how many medical device manufacturers maintain both ISO 9001:2008 and ISO 13485:2003 certification.It would be really goo...
    « Previous 1 … 3 4 5 6 7 … 15 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

      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.