1/27/2024 0 Comments Aami tir45 pdf download![]() ![]() Finally, further relevant topics are addressed, such as the European Data Protection Regulation or digital health applications on prescription and how, perhaps, the European approach could benefit from FDA approaches. ![]() In addition to relevant documentation requirements, this survey provides guidance on the most important future developments of IT standards in Europe. Topics such as the software lifecycle, the continuously growing importance related to IT security, and hot topics such as agile software development, artificial intelligence, and machine learning are addressed, and recommendations are given on how to meet the regulatory requirements. ![]() This chapter firstly provides an overview of well-known challenges in the approval process of software as a medical device, and secondly suggests methods to meet all requirements. Software as a medical device (SaMD) has attracted enormous attention in recent years as safety requirements have dramatically increased due to the MDR 2017/745 (2017a) and the IVDR 2017/746 (2017b), as well as other standards relevant to the approval process. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |