IMDRF
The new article describes in detail the approach to be applied with respect to communication-related matters during the support stage of the total product life cycle. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), an association of...
IMDRF
The new article describes in detail the approach to be applied with respect to the third and fourth stages of the total product life cycle, as well as to the risk assessment in the context of transition between the stages. Table Of Contents: The International Medical...
IMDRF
The new article highlights the aspects related to the first two stages of the total product life cycle, namely the initial development, when the product is being created, and support – the period that starts from the moment the product becomes available on the...
IMDRF
The new article addresses the aspects related to establishing efficient communication between medical device manufacturers and healthcare providers with respect to medical devices used and also provides definitions of the most important terms and concepts. Table Of...
IMDRF
The new article addresses the aspects related to the initial design development stage in terms of design and controls intended to ensure a medical device’s continued safety and proper performance. In particular, the article outlines the main responsibilities of...
