Most medical device regulators require medical devices to be designed and manufactured under a Quality Management System (QMS), they also require risk management of the product. So how do you build a QMS? Where do you start?
Watch the video below to learn how to start.
Medical device regulation can be complex, depending upon the product. However, it is often not what people expect because the focus managing risk and quality, rather than telling you what features are allowed.
The Australian regulations for medical device software, including Software as a Medical Device (SaMD), are undergoing reform. In April 2020 the Therapeutic Goods Administration (TGA) published a consultation paper on the scope of regulated software-based medical devices. Read our response here.