The new article focuses on fluoroscopic X-ray systems and the regulatory requirements established, particularly changes effective on June 10, 2006, providing guidance on compliance, system modifications, and operational features.
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.
The new article provides further clarifications regarding the clinical follow-up and supervision to be conducted by the parties responsible for clinical investigations.
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.