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How to build a quality management system for a medical device

by Platypus Technical | Feb 16, 2021 |

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.

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How to get a medical device approved in Australia

How to get a medical device approved in Australia

by Platypus Technical | Jan 27, 2021 |

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.

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Response to TGA Consultation – Scope of regulated software-based products

Response to TGA Consultation – Scope of regulated software-based products

by Lee Walsh | May 11, 2020 |

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.

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