Software medical devices, mobile health, telehealth and telemedicine are revolutionizing how people worldwide achieve higher standards of health, and access services to promote and protect their health.
Yet, those medical devices vulnerable to cyberattacks, potentially impacting the safety and effectiveness of the device. Also, the FDA has made it clear that it expects "trustworthy devices" that is a medical device(s) containing hardware, software, and/or programmable logic that: (1) is reasonably secure from cybersecurity intrusion and misuse; (2) provides a reasonable level of availability, reliability, and correct operation; (3) is reasonably suited to performing its intended functions; and (4) adheres to generally accepted security procedures.
Our mission is educate, train and assist Medical Device Manufacturers, Hospitals and other Health Delivery Organizations in managing cybersecurity risks thereby minimizing any adverse impact to patients, and the organization.
John Giantsidis is the President and Founder of CyberActa, Inc. He brings over 22 years of industry experience and a deep understanding of the rapid development and constantly changing landscape of our industry. Before founding CyberActa, he held various Compliance, Digital Quality Systems, Data Governance, and Software Integration roles with Integra LifeSciences, Fresenius Medical Care, and Bristol-Myers Squibb Co.
Outside of CyberActa, John is a leader on topics including medical device cybersecurity, digital ecosystem management, and data governance. John is a member of the US Marine Corps Cyber Aux, a small cadre of highly-talented cyber experts who train, educate, advise, and mentor Marines to keep pace with cyber challenges.
John holds a Bachelor of Science degree from Clark University, a Juris Doctor degree from the University of New Hampshire, and a Master of Engineering in Cybersecurity Policy and Compliance from The George Washington University.
John can be reached @John.Giantsidis@cyberacta.com
Jim Isaacson is CyberActa's Product Development expert with over 32 years of experience in the Medical Device industry. Jim’s expertise in the development of Medical Devices, including Project Management, Design Controls, Risk Management, and Process Validation will enhance clients’ capabilities in their product development processes.
His work experiences include extensive project management, personnel management, Design Controls, Design of Experiments, statistics, and life cycle product management. He uses a market-driven business approach, with targeted creativity resulting in strong IP protection (co-inventor of 27 patents). He provides a unique balance of communication skills and customer interface experience with a strong technical background. His style is one of open, honest, and direct two-way communication within any work environment.
He provides a unique balance of communication skills and customer interface experience with a strong technical background.
Jim can be reached @Jim.Isaacson@cyberacta.com
Our broad knowledge and deep industry expertise allow us to develop next-gen services to protect your business, from end to end. We provide the missing piece, so you have a peace of mind.