TGA Medical Device Essential Principles Checklist
The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.
The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.
The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.
The article provides a general overview of the UK regulatory framework for clinical investigations related to medical devices intended to be marketed and used in the country.
The new article elaborates further on the aspects related to risk management in the context of medical devices to be used in the course of clinical investigations.
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