Analysis & Clarification of the FDA Post-Market Device Cybersecurity Management Guidance


(Arlington, VA) – Q1 Productions is hosting the 2nd Annual Medical Device Cybersecurity Risk Mitigation Conference on July 17-18 in Arlington, Virginia. With the post-market final guidance being released in December, the content is very new and relevant to the industry’s current challenges. There will be regulator perspectives (FDA), security organizations (ISAO, NH-ISAC), and industry leaders coming together to provide insights on the evolving space of medical device cybersecurity. This will be a very interactive conference with solo presentations, co-presentations, fireside chats, panels, and open discussions.


With increasingly public examples of cybersecurity breaches, the industry is under more pressure than ever to continuously identify vulnerabilities and ensure robust threat response strategies. “The concern around medical device security has hit the mainstream. When family members start asking me if their pacemaker can be hacked, I know that this has become a big issue.” Mike Kijewski, CEO of MedCrypt explained to Q1 Productions “If they want to be market leaders, medical device companies will need to convince their customers and patients that they’re providing the safest products possible.”


Organizations currently manufacturing medical device products and working with cybersecurity, will find this conference of tremendous interest. When asked about the conference, Bill Hagestad, Senior Principal Cybersecurity Engineer at Smiths Medical exclaimed, “Last year’s event was superb! The industry representation was remarkable and the chance to meet peers as well as the FDA was invaluable!” With dozens of years of combined experience specific to the device and diagnostic industries, presenters will address valuable presentations highlighting both the challenges faced by manufacturers, as well as strategies for overcoming the increasingly evolving cybersecurity community.


Industry leaders from organizations such as Siemens Healthcare, Medtronic and GE healthcare will lead solution driven, in-depth discussions about common industry challenges, providing a better understanding of how other companies are successfully furthering development plans for ISAO, NH-ISAC & MDISS, and successfully implementing cybersecurity into general design processes- ensuring technical scrutiny throughout product design.
For more information on the Medical Device Cybersecurity Risk Mitigation Conference, or any of Q1 Productions’ upcoming conferences, please visit You can also follow Q1 Productions on Twitter, @Q1Productions, #Q1Cyber.