Enhancing Medical Device Cybersecurity & Patient Safety across the Product Lifecycle, Understanding the Recent FDA Pre & Post Market Guidance, all while Optimizing Risk Assessment & Mitigation Operations for Marketed as well as New Product Pipelines
July 25-26, 2016 | Arlington, VA | Hyatt Arlington Hotel
ABOUT THE CONFERENCE:
As medical device manufacturers continue to develop life improving products that include cutting-edge technology for patients across the globe, it is becoming increasingly important to implement cybersecurity measures throughout the product life cycle, to ensure continuous product and patient safety. Devices connected to the internet, or to specific IT networks, face an increasing number of threats, and in particular that of being accessed by external parties such as hackers. With the FDA’s new post market guidance released in January 2016 and previous pre-market guidance released in 2014, it is critical for cybersecurity executives to establish in-house processes to comply with regulatory requirements when integrating cybersecurity in a medical device product line. Furthermore, risks related to areas of high level of technicity such as cloud security, digital signatures and medical device apps are continuously challenging cybersecurity teams due to the extremely rapid pace at which such technologies evolve.
Presenter perspectives will draw on a wide variety of stakeholders in the industry, including medical device manufacturers, health care providers and the FDA, which all play an active role in cybersecurity maintaining and implementing. Topics addressed will cover changes to regulations including the new FDA pre-market and post-market guidance, as well as practical insight into industry operations and practical steps towards compliant and efficient cybersecurity. Case study sessions by professional hackers will also provide a unique point of view, focusing on customer risks. Throughout the program, presenters will share best practices, engaging the audience to discuss the development of a robust cybersecurity plan where organizations can support the shared goal of working safely and effectively with connected device products.