PLATYPUS MEDTECH

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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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Validation - proving it does what you designed it for

Validation is a vital concept when it comes to proving what things do.  It is a term commonly used by engineers, scientists, physicians and other people working in evidence based professions.  Validation is also a vital part of product quality assurance.  I usually need to explain how I have validated a new method or tool […]

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Platypus MedTech Consultants Pty Ltd
+61 2 6198 3242
enquiries@platypusmedtech.com.au

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 and Ngarigo people. 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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