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Webinar: Essential Principles to software

13 August 2019

Overview

Australia's regulation of medical devices is principles-based, which allows freedom for manufacturers and flexibility for novel products. However, it can also be unclear to inexperienced manufactures and developers what is expected to demonstrate compliance. This webinar will provide an introduction to how the Essential Principles can be applied to medical device software, including software as a medical device (SaMD).

Who should attend?

Software developers, manufacturers and sponsors that are producing or sponsoring products that are, or include, medical device software and are not familiar with how to demonstrate compliance with the Essential Principles.

Background

The Essential Principles are the legislated requirements for safety and performance of all medical devices in Australia (regardless of classification). Manufacturers determine the intended purpose of their medical device, and get freedom in how they demonstrate compliance with the Essential Principles. This system provides flexibility for novel products, but can make it challenging for new manufacturers who are unfamiliar with medical device regulation, or producing evidence of compliance.

Standards are a useful tool that can be applied to medical devices, but are not always sufficient to meet the requirements of the Essential Principles. Risk management is fundamental and it is difficult to demonstrate compliance with the Essential Principles without being able to demonstrate good risk management.

How do I register?

  • Date: Thursday 5 September 2019
  • Time:12:30-13:30 AEST
  • Presentation by: Lee Walsh

Register for webinar