content
In the development of medical software, in addition to the technological know-how of software development, knowledge of the normative requirements and their concrete implementation as well as mastery of the development process over the entire software life cycle is required. This seminar gives a comprehensive overview of the topics of development, quality assurance and approval of medical software. The aim is to get to know the central normative requirements in order to be able to implement them for your own application.
topic overview
- Requirements of the relevant laws, standards, guidelines and their connections
- Comparison of the approval procedures EU vs. USA (FDA)
- Overview of IEC 62304
- software development process
- software architecture
- Software Risk Management Process
- Software verification and validation
target group
System and software developers as well as software risk managers, software usability engineers, project managers and those responsible for regulatory affairs and quality management.
previous knowledge
Basic knowledge of regulatory affairs and quality management is recommended, but not mandatory.
KONTAKT:
Online
