Compact Seminar Medical Software and IEC 62304

Get a comprehensive overview of the regulatory framework in order to classify your device properly

You will first learn about the legal requirements applicable in the EU as well as relevant standards and directives. You will then be able to determine whether your software is a medical device and which tasks and documents to create based on the corresponding risk class. We can also present the differences with regard to FDA requirements so that you can take these into account.

Learn how to optimally design and document your software development process with the help of examples and exercises

You will learn how to optimally design or improve your software development process using appropriate case studies and exercises. Among other things, we will also show you how to align agile development practices with other regulatory required processes. You will also acquire a sense of how extensive and detailed the documents in the software file should be.

Benefit from the experience of our expert and get your software through the audit without any problems

Our expert has worked as a software developer and project manager himself for several years in the past, primarily managing the required software files. Therefore, he knows all too well the different perspectives on the development and approval process and can provide you with useful tips, best practices, and rules of thumb to pass your audit safely and without unnecessary effort.

You can find the exact learning content as well as the schedule of the seminar in the agenda: