The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a discussion paper dedicated to the proposed regulatory framework for modifications to the software as a medical device (SaMD) based on the artificial...
The Federal Agency for Medicines and Health Products (FAMHP), the Belgian regulating authority in the sphere of medical devices, has published updated guidelines for clinical trial sponsors. The document is intended to provide additional recommendations and...
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for local medical device manufacturers intended to provide additional clarifications and recommendations. The scope of the guidance covers aspects such as preparation for applying for...
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance dedicated to the custom-made medical devices and applicable regulatory framework. The scope of the document covers all custom-made medical devices, including the active...
The Philippines Food and Drug Administration (FDA) has published a circular implementing the interim guidelines describing the conduct of licensing inspections for radiation facilities. In the case of any discrepancies, the provisions of the new circular shall...
The Medicines and Healthcare products Regulating Agency (MHRA) of the UK has updated its guidance for medical device manufacturers initially published in December 2014. In particular, the document provides additional clarifications and recommendations regarding how...
Please fill out the form below and one of our team members will get back to you as soon as possible!
Request A Demo
Please fill out the form below and one of our team members will get back to you as soon as possible!
We use cookies to understand how you use our site and to improve your experience. By continuing to use our site, you accept our use of cookies. Find out more.