EU
The article highlights the key points related to the regulatory status of legacy devices.
EU
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
FDA
The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
FDA
The new article describes in detail certain specific aspects related to the regulatory status of endosseous dental implants and performance criteria they should meet in order to be allowed for marketing and use in the US.
Medical Devices
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance. As connected devices become increasingly prevalent, cybersecurity has become a critical concern in regulatory submission.
FDA
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
