With the development of information and communication technology, the number of wired and wireless communication medical devices is increasing. As a result, cases of cybersecurity threats such as hacking and information leakage are steadily increasing.
For this reason, the application of cybersecurity in medical devices has been strengthened because it can directly harm patient life.
Medical device cybersecurity requires consideration of Availability, Confidentiality, and Integrity.
The targets and submissions for cybersecurity are generally as follows.
< Subject to mandatory cybersecurity submission >
1. Medical devices containing software
: Medical devices including Firmware and Programmable Logic Controller
2. Medical devices that exist only in software
: Among SaMD, medical devices that use wired/wireless communication(Wi-Fi, Bluetooth, USD, RS-232, LAN etc.) or have a communication path
<Cybersecurity Submission Document Item >
1. Medical Device Cybersecurity Requirements Checklist
2. Data that validate cybersecurity requirements
- Software Verification and Validation Materials
- Cybersecurity Risk Management Document
- Performance test report
3. Data to confirm the basis for not applying cybersecurity requirements
- Cybersecurity Risk Management Documents, etc
Please refer to the link below for details.
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net