Dec 2, 2019
North America
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on manufacturing and performance of medical devices,...
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Sep 25, 2019
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...
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Mar 11, 2019
EU MDR/IVDR
The European Medicines Agency (EMA) recently released a guidance document regarding the new EU MDR, which will go into full effect in May 2020. This guidance focuses on the responsibility manufacturers will take in the registration process for combination devices with...
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