Oct 12, 2023
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...
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Oct 12, 2023
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...
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Oct 11, 2023
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...
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Oct 11, 2023
Asia
This article highlights key steps and considerations for medical device companies to establish effective design controls. Table of Contents Design controls are a crucial aspect of the medical device development process.They ensure that medical devices are safe,...
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Oct 10, 2023
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
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