
FDA Q&A Document on Electronic Records: Retention and Management
The new article explains the approach to be followed in the context of retention and management of electronic records.
The new article explains the approach to be followed in the context of retention and management of electronic records.
The article highlights the key points related to the use of electronic records based on the applicable legislation.
The article outlines the basics of the existing Turkish regulatory framework for the distribution of medical devices.
The new article provides additional clarifications regarding certain specific regulatory aspects, including the applicability of the marketing legislation.
The new article describes in detail the approach to be applied with respect to information used to promote medical devices allowed for marketing and use in the country.
The final article of the cycle explains the specific metrics to be measured in the course of clinical studies in order to collect accurate and reliable information regarding the products in question.