MDCG Guidance on Standardisation for Medical Devices: Overview
The document outlines the approach to be followed in order to ensure standardisation for medical devices, facilitating further harmonisation of the relevant regulatory requirements.
The document outlines the approach to be followed in order to ensure standardisation for medical devices, facilitating further harmonisation of the relevant regulatory requirements.
The new article describes in detail the relevant harmonised standards applicable to medical devices, and also the way they should be applied.
The article highlights the key points related to the application of certain essential principles intended to ensure the safety and proper performance of healthcare products allowed to be marketed and used in Australia.
The new article provides further details regarding the particular approach to be followed in order to achieve and maintain compliance with the relevant regulatory requirements.
The article provides a brief overview of the approach to be applied when using standards for demonstrating compliance with the relevant regulatory requirements.
The new article explains further the way the approach described in the document should be implemented.
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