Mar 4, 2024
EU
The article provides a general overview of a vigilance system applicable to CE-marked medical devices intended to be marketed and used in the EU and also highlights certain specific aspects associated thereto.
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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 4, 2023
GMDN
This aticle highlights the importance of Medical Devices in the healthcare industry highlighting their key uses, developments and emerging technologies in the sector. Table of Contents Over the past few decades, there has been a significant evolution in medical...
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Oct 4, 2023
CDRH
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...
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Sep 29, 2023
Canada
The article highlights the aspects related to the regulatory status of such categories as “medical device group”, “medical device group family” and “medical device system”. Table of Contents Health Canada, the Canadian regulating authority in the sphere of healthcare...
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