EU MDR/IVDR
This article highlights the fundamentals of EU medical device regulation, highlight the top priorities for 2023, and explore how individuals and organizations can become more involved in the changing landscape. Table of Contents The European Union (EU) has implemented...
CDRH
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
CDRH
This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential insights for manufacturers and healthcare professionals navigating the regulatory landscape Table of Contents In the...
CDRH
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...
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