Navigating Global Cybersecurity Regulatory Requirements for Medical Devices
Major advances in medical technologies over the last few decades have contributed to early diagnosis of diseases, more efficient delivery of treatment, and longer, healthier ...
Location details: Conference B, SKY31 Convention, 31F Lotte World Tower (300 Olyimpic-ro, Songpa-gu, Seoul)
Time: 13:30~18:00 (Reception: 13:00~13:30)
Cost: Free of charge
Major advances in medical technologies over the last few decades have contributed to early diagnosis of diseases, more efficient delivery of treatment, and longer, healthier lives. Network-connected medical devices in particular are redefining 21st century healthcare. With many life-sustaining and life-supporting medical devices residing on hospital networks – and many more connected wirelessly – the risk for cyber-attack is high, and this could compromise a device’s functionality, personal information, and patients’ health and safety. Implementing cybersecurity measures for devices and the networks to which they connect is critical, and CSA Group’s cybersecurity services can help.
Join CSA Group’s Laura Élan, Senior manager of Cyber security as she addresses the following:
- Overview of Cybersecurity Regulatory Guidance with an Emphasis on US FDA Pre/Post Market Guidance
- Overview of Cybersecurity Frameworks and Standards to Support Medical Device Manufactures
- Essential Activities for Medical Device Companies to Address Product Cybersecurity
- Introduction to Security Risk Analysis for Medical Device and Software Manufactures
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