FDAnews Announces — Medical Device Cybersecurity Quality Assurance: Requirements, Best Practices and Innovative Approaches Webinar, June 23, 2015

Network connectivity opens up a wealth of possibilities for medical devices, but it also exposes a minefield of potential liabilities. Devices transmit data on the user’s condition to healthcare professionals, but can manufacturers be sure the information doesn’t fall into unauthorized hands? Even more vitally, if a device can send data out, malware or hackers could possibly get in. How can a manufacturer guarantee an attacker won’t be able to affect its functionality?

Before risking having devices compromised, learn both sides of the facts from two of the field’s top experts – one in systems engineering and design, the other in hacking and reverse engineering.

Sign up now to attend the FDAnews webinar Medical Device Cybersecurity Quality Assurance on Tuesday, June 23, 2015.

Learn what medical device manufacturers should be doing with their quality assurance strategies to protect their devices. Plus, learn how other industries are dealing with this issue through responsible disclosure policies and what these policies mean to the relationship with regulators.

Specifically, attendees will learn:

• How a hacker views a target, what motivates them, and what makes a device a target
• Real-life scenarios of cybersecurity breaches and their consequences — even an attack not aimed at a device could interfere with it
• The path to incorporate cybersecurity into quality assurance and safety risk analysis and why cloud connectivity might not be a good idea
• The elements of an effective, cross-functional cybersecurity team
• The difference is between a “black hat” and “white hat” hacker
• The best practices used to address cybersecurity in other industries, and practical ways medical device manufacturers may apply these
• Information about FDA’s pre-market cybersecurity guidance released in October 2014
• Policies and procedures companies may consider to prepare for FDA’s upcoming release of post-market surveillance expectations

Meet the Presenters:
Melissa Masters, RAC, (B.S., Electrical & Computer Engineering)
Ms. Masters heads Battelle’s DeviceSecure™ Services and has more than 12 years of experience in product development as a project manager, systems engineer and design engineer. She serves as the project manager and lead systems engineer on medical device development programs, as well as sustaining engineering programs. Her responsibilities include project management, task management, leading risk assessments, writing and testing system and subsystem requirements, testing of clinical and prototype devices and conducting clinical trials.

Stephanie Preston, CEH, GSEC, EIT, (B.S., Electrical & Computer Engineering)
Ms. Preston is a Certified Ethical Hacker (CEH) in Battelle’s Cyber Innovations team, where she focuses on firmware reverse engineering (x86, x86_64, MIPS, 8051), as well as application development (C/C++). She also serves as the team’s intellectual property steward, and chairs the Battelle Vulnerability Disclosure Council. Ms. Preston is a registered engineer in training (EIT) in the state of Ohio, holds a (GSEC) Global Information Assurance Certification (GIAC) Security Essentials certification, and a Certified Ethical Hacker (CEH) certification.

Who Will Benefit:

• QA/QC personnel
• Data management and statistics personnel
• Engineering and design controls teams
• Risk management specialists
• Compliance officers

Webinar Details:
Medical Device Cybersecurity Quality Assurance:
Requirements, Best Practices and Innovative Approaches
**FDAnews Webinar**
June 23, 2015 — 1:00 p.m. – 3:00 p.m. EDT
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