Asia
The Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices regulation, published a brochure providing an overview of the existing regulatory framework. The document covers the most important aspects related to medical...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued an enforcement policy dedicated to the telethermographic systems in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused...
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
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