Regulatory Open Forum

 View Only

  • 1.  Professional Liability Insurance

    This message was posted by a user wishing to remain anonymous
    Posted 18-Feb-2020 09:45
    This message was posted by a user wishing to remain anonymous

    Hello RAPS World!

    I have a question for all of you consultants out there - does anyone have any recommendation(s) for a carrier for professional liability insurance?  I have tried looking for one without much success as the companies that I have contacted do not provide coverage for our industry because we are considered 'high risk'.

    Any leads would be helpful and very much appreciated!

    Thank you!!


  • 2.  RE: Professional Liability Insurance

    Posted 19-Feb-2020 10:21
    Edited by Matt Winton 19-Feb-2020 10:22
    RAPS members can obtain professional liability insurance through Vaughan Insurance, and it's exactly what you're looking for.  That's who I have my own liability insurance through.  I've found Vaughan very easy to work with in terms of making changes/additions to my insurance as needed.

    Look for the link in your list of member benefits.

    ------------------------------
    Matt Winton
    Winton Consulting LLC 
    Leander TX
    United States
    ------------------------------

    Original Message


  • 3.  RE: Professional Liability Insurance

    Posted 20-Feb-2020 02:46
    Hi Matt,

    Thank you for your response. As I am also interested about the insurance because of the new EU Person Responsible for Regulatory Compliance requirement acc. to MDR, I wanted to inquire if you would be knowing an insurance company which would also provide their services for clients based in Germany (Europe)?

    Thanks and regards,
    Parin

    ------------------------------
    Parin Shah
    Tübingen
    Germany
    ------------------------------

    Original Message


  • 4.  RE: Professional Liability Insurance

    Posted 20-Feb-2020 03:12
    Hi Parin, as far as I know there are no liability requirements in the MDR associated with the ​PRRC.
    For both Manufacturer and Authorized Representative liability requirements are identified in the MDR, and both have to have a PRRC, but I cannot find that the PRRC is personally liable. Article 15.4 explicitly states that 'the person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.'.
    Of course as an independent consultant you want / need to have a professional liability insurance, but that's another discussion.

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 5.  RE: Professional Liability Insurance

    This message was posted by a user wishing to remain anonymous
    Posted 22-Sep-2020 08:54
    This message was posted by a user wishing to remain anonymous

    Hi all, 
    i'll go slightly off topic if you don't mind. Does any of you have an insurance company to recommend and an idea of prices to cover risks (liability, eventual adverse events to operators and or patients) for a small US clinical study on a medical device.
    Thanks
    Original Message


Related Content