The new article describes in detail the second section of the document addressing mostly the matters related to the risks associated with a medical...

The article provides a general overview of the critical points associated with the registration procedures for healthcare products intended to be marketed and used...

The new article provides an overview of the medical device registration process in general. Also, it describes in detail the approach to be followed...

Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue opportunities....

The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication...

The new article describes in detail the applicable types and classes of recalls and also explains the difference between recalls and non-recall actions from...

The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent...

The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market. ...

The new article describes the approach to be applied concerning reporting and record-keeping in the context of clinical investigations associated with medical devices intended...

The article highlights the critical points related to the recall procedures applicable to medical devices allowed for marketing and use in Canada. ...

The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved. Table...

The new article describes in detail the recall process, highlighting the most important aspects associated with it. Table of Contents ...