As a guest user you are not logged in or recognized by your IP address. You have
access to the Front Matter, Abstracts, Author Index, Subject Index and the full
text of Open Access publications.
The quality of software is high in medical devices due to the strict regulatory requirements and their implementation in the software development processes through the use of the IEC 62304 standard. The goal of this standard revision project was to extend the scope of the standard to all health software and also to bring the requirements of the 12 year old standard back to the state-of-the-art including provisions for cybersecurity. The joint IEC/SC62A and ISO/TC215 project team revised the standard and adapted its risk management, usability, and security requirements to serve both the medical device industry and the overall health software industry. The resulting second version of the standard has gone through a multistage global voting process to achieve a consensus of the requirements to serve both these communities. The resulting standard has potential to have a major impact on the quality of software used in health care globally.
This website uses cookies
We use cookies to provide you with the best possible experience. They also allow us to analyze user behavior in order to constantly improve the website for you. Info about the privacy policy of IOS Press.
This website uses cookies
We use cookies to provide you with the best possible experience. They also allow us to analyze user behavior in order to constantly improve the website for you. Info about the privacy policy of IOS Press.