Broadly speaking, a medical device is considered to be any article that is not a medicine, and that is used for the diagnosis, prevention, monitoring, treatment or alleviation of a health condition.
Broadly speaking, a medical device is considered to be any article that is not a medicine, and that is used for the diagnosis, prevention, monitoring, treatment or alleviation of a health condition.
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.
Platypus MedTech Consultants Pty Ltd
+61 2 6198 3242
enquiries@platypusmedtech.com.au