EDA
The new article explains in detail the approach to be followed with respect to safety reporting in the context of clinical investigations conducted in order to assess the safety and effectiveness of medical devices intended to be marketed and used in Egypt.
Great Britain
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.
EU
The article provides a general overview of the approach to be followed when creating a clinical investigation plan for medical devices.
EU
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
