How to build a quality management system for a medical device

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

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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Platypus MedTech Consultants Pty Ltd
+61 2 6198 3242

Level 1, The Realm, 18 National Circuit
Barton, ACT 2600
Platypus MedTech Consulting acknowledges that we live and work on the land of the Ngunnawal, Ngarigo and Whadjuk Nyoongar peoples. We also acknowledge the Traditional Owners of Country throughout Australia where we deliver our services. We recognise their connections to land and waters, the sophistication of First Nations knowledge and their contributions to engineering and science. We pay respect to their Elders, engineers and scientists, both past and present.
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