Marc Brown, CMO and VP of Strategic Business Development, GrammaTech, Inc. to Speak at TKG's WebcastMarc Brown, CMO and VP of Strategic Business Development, GrammaTech, Inc. to Speak at The Knowledge Group's Medical Device Software Development: Liability Risk Mitigation 2016 LIVE Webcast
For further details, please visit: https://theknowledgegroup.org/ About Marc Brown Marc brings over 20 years of technology leadership experience to his role as Chief Marketing Officer. Before joining GrammaTech in June of 2015, Marc was the Group VP of Product and Solutions Marketing at Polycom, where he helped define and market Polycom'sWorkplace of the Future. Prior to Polycom, Marc spent several years in the embedded software markets with Intel, Wind River Systems, and IBM, leading several marketing teams. Earlier in his career, Marc was a software engineer with Corning Research and GE Aerospace. Marc has a degree in Mathematics from the State University of New York. He lives in Phoenix with his wife of 26 years and three children. About GrammaTech, Inc. GrammaTech is a leading developer of software-assurance tools and advanced cyber-security solutions. We help organizations develop and release high quality software - free of harmful defects and exploitable weaknesses that cause system failures, enable data breaches, and increase corporate liabilities in today's connected world. With our security-first software design philosophy, you can rely on GrammaTech to help you design, develop, and deploy trusted software applications, using advanced static analysis tool and software hardening solutions. Unlike other traditional tools vendors, GrammaTech's mission balances a commercial business with a very strong research arm. Our staff, including over 20 PhDs, is focused on the most challenging software issues impacting the embedded, M2M, and IoT equipment markets, through a stream of highly innovative research programs advancing techniques and technologies in software analysis, transformation, monitoring, and autonomic functions. Event Synopsis: With the advent of the Internet-of- In 2014, the US Food and Drug Agency (FDA) issued non-binding guidance for manufacturer's pre-market management of cyber security of medical devices. The agency suggested conformity to certain industry standards, ensuring authentication of users, controlling access, and detecting, mitigating, and recovering from cyber security attacks. In 2015, the FDA reported that software design failures were the most common cause of device recalls and proposed new guidelines for manufacturers. The agency issued non-binding guidance for for post-market management of cyber security of medical devices. In this non-binding guideline, the agency suggested the need for control and mitigation of cyber security risk through software patches, hardware updates, threat modeling and vulnerability assessment, risk management, and attack remediation. Developing safe and effective medical devices requires a rigorous validation process. However, such validation is time-consuming and costly. Many developers use third-party code, such as commercial off-the-shelf software or re-use code for efficiency and cost reduction. Yet, much of this code is dated and fails to pass security and vulnerability testing. As such, medical device software development has not kept pace with the demands for greater security, up-grading, patching, and inter-operability in hospital and other settings. To cope with these challenges, medical device software development teams must shorten development time, upgrade software, enable patching, enhance security, and provide safer and more effective products that comply with current ISO, IEC, FDA, and other standards. Manufacturers need to incorporate cyber security features into devices during the design and development phase. They also need to enable retrograde patching of older devices. Binary static analysis will enable robust analysis of third-party software, ensuring that it conforms to the device quality and security standards. Lifecycle management systems should be used to help detect, identify, and manage cyber security vulnerabilities. Finally, manufacturers also need to provide clear pre-market cyber security documentation and support for customers. In this two hour, LIVE Webcast, a panel of thought leaders and practitioners organized by The Knowledge Group will provide an overview of the latest issues in Medical Device Pre-market and Post-market Security Risk Mitigation. Speakers will also help medical device manufacturers and health software developers better understand how to minimize pre- and post-market liability through proper risk analysis and mitigation, and compliance with relevant standards and regulations. Key issues that will be covered in this course are: § Medical Device Hardware and Software Development § Cyber Security and Safety Risks § Risk Analysis and Mitigation § Risk Management Systems § Relevant Industry Standards § IEC 61508 § IEC 62304 § FDA Validation Guidance § Pre- and Post-Market Analysis and Liability § Trends and Challenges for Medical Technology Providers § Reliability, Safety, Security, and Quality Control § Changing Regulations & Compliance Risks § Best Practices About The Knowledge Group/The Knowledge Congress Live Webcast Series The Knowledge Group was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register for an event, please visit: http://theknowledgegroup.org/ End
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