This article provides a comprehensive analysis of the regulatory frameworks governing post-market surveillance activities in Europe and the US. It identifies critical differences, challenges, and best practices for manufacturers operating in these markets. It is also essential to maintain medical devices, and the article elucidates the challenges faced by healthcare facilities and manufacturers while offering strategic insights for maintaining medical technology. The article also investigates the critical aspects of maintaining Software as a Medical Device (SaMD), providing assertive insights and best practices for ensuring these innovative solutions continue to meet regulatory standards while delivering optimal patient care.
Introduction
The journey of a medical device, from its inception to its release in the market, is an amazing feat of innovation and regulatory compliance. However, the responsibility of manufacturers does not end once the device is released on the market. In the European Union (EU) and the United States (US), the post-market phase is heavily regulated to ensure that medical devices continue to perform safely and effectively throughout their lifecycle. Moreover, maintenance is an essential aspect of all types of medical devices, even after they have been released in the market. In particular, the maintenance of Software as a Medical Device (SaMD) presents unique challenges and opportunities compared to traditional medical devices.