FDA
The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...
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...
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
CDRH
This article provides insights into 21 CFR Part 820, including an overview of the regulation, its requirements, and compliance strategies. Table of Contents The US Food and Drug Administration (FDA) is responsible for regulating medical devices marketed in the United...
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...
