EU MDR/IVDR
This article highlights the fundamentals of EU medical device regulation, highlight the top priorities for 2023, and explore how individuals and organizations can become more involved in the changing landscape. Table of Contents The European Union (EU) has implemented...
Canada
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
CDRH
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
CDRH
This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential insights for manufacturers and healthcare professionals navigating the regulatory landscape Table of Contents In the...
Medical Devices
This article highlights he differences between intended use and indications of use, along with their significance. Table of Contents In the highly regulated world of medical devices, precision in terminology makes a significant impact. It is important for preparing...
