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...
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...
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...
This article talks about USFDA Medical Device Approval Timeline as per their Classification. Table of Contents The process of getting FDA approval for a medical device can be lengthy and complex.The time it takes for a medical device to receive FDA approval can vary...
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...