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,...
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...
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...
CDRH
This article highlights the procedure, key points and Benefits of the USFDA eSTAR Submission Programme. Table of Contents eSTAR Submission According to the FDA announcement in September, businesses can now submit premarket applications electronically via the CDRH...
EU MDR/IVDR
This article highlights the importance of GSPR compliance for obtaining medical device approval in the European Market. Table of Contents The European Union (EU) has implemented stringent regulations and requirements for the approval and launch of medical devices...
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