Regulatory Open Forum

 View Only

Regulatory Gap Assessment for Australia

  • 1.  Regulatory Gap Assessment for Australia

    This message was posted by a user wishing to remain anonymous
    Posted 17-Feb-2022 16:01
    This message was posted by a user wishing to remain anonymous

    Hi,

    Does anyone have a gap assessment template for Australia MD regulations (Therapeutic Goods (Medical Devices) Regulations 2002) they're willing to share? Looking for a template that would include the latest amendment.

    I am looking to do a gap analysis to show that all regulatory requirements have been incorporated into our quality system.

    Many thanks.