With the rapid development of core technologies of the 4th Industrial Revolution (big data, artificial intelligence, hyperconnectivity, etc.), the importance of Software as Medical Device (SaMD) has emerged.
Conventional medical software was built into hardware medical devices to support the hardware, but recently, the software itself provides functions that correspond to the definition of a medical device.
Although SaMD itself can not replace doctors, it helps to treat patients more effectively, such as disease prediction, clinical decision support, and patient-medical personnel interaction.
‘SaMD Special Exhibition’ focuses on software medical devices integrated with information and communication technology.
With the rapid development of core technologies of the 4th Industrial Revolution (big data, artificial intelligence, hyperconnectivity, etc.), the importance of Software as Medical Device (SaMD) has emerged.
Conventional medical software was built into hardware medical devices to support the hardware, but recently, the software itself provides functions that correspond to the definition of a medical device.
Although SaMD itself can not replace doctors, it helps to treat patients more effectively, such as disease prediction, clinical decision support, and patient-medical personnel interaction.
‘SaMD Special Exhibition’ focuses on software medical devices integrated with information and communication technology.
- Information and communication technologies such as AI, Cloud, and IoT are integrated with the medical industry, and it is becoming an important technology in the global healthcare market.
- Interest in diagnostic areas that combine big data and artificial intelligence is rising, and cloud use has become the standard for DNA analysis as well as new drug development.
- Expected to improve the level of medical treatment with the Metaverse solution.
2. Government’s policies to foster the software and medical device industry
- Clinical approval, screening, production facilities & quality control standards, distribution & sales management system are reorganized according to the nature of software medical devices.
- The number of software medical device items classification and categorization has also been greatly expanded from 90 to 140.
- Leading the development of international guidelines for AI SW medical devices for the first time in the world and promoting government R&D to secure SW medical device technology.
2. Government’s policies to foster the software and medical device industry
- Clinical approval, screening, production facilities & quality control standards, distribution & sales management system are reorganized according to the nature of software medical devices.
- The number of software medical device items classification and categorization has also been greatly expanded from 90 to 140.
- Leading the development of international guidelines for AI SW medical devices for the first time in the world and promoting government R&D to secure SW medical device technology.
