WEBINAR SERIES
Cybersecurity In Medical Devices
Practical Advice for FDA’s 510(k) and PMA Cybersecurity Requirements
Meet FDA Expectations
BG Networks’ (BGN) and our partners are offering a series of webinars on meeting the FDA’s expectations for cybersecurity in medical devices and Software as a Medical Device (SaMD). Our goal with this series of 9 webinars is to provide information and advice to help you make your devices secure and to prepare the cybersecurity aspects of your FDA premarket submissions.
On Demand and Upcoming Webinars
Webinars that have already been presented are available on demand and listed below. They are followed by a list of webinars we will be presenting over the course of the year. By the end of the series, we will have covered considerations for medical device cybersecurity for the Total Product Lifecycle. That is from the beginning of a design to FDA premarket submission, to post market activities.
BG Networks Medical Device Webinar List
SEPTEMBER:
Threat modeling and risk assessment – First step in risk management
COMING SOON
DEFENSE-IN-DEPTH:
Security control categories called for by the FDA
COMING SOON
CYBER-TESTING:
Security Requirements, Threat Mitigation, Vulnerability Testing, Penetration Testing
COMING SOON
CYBERSECURITY DOCUMENTATION:
eSTAR submissions
COMING SOON
POST-MARKET REQUIREMENTS:
Fixing Vulnerabilities: SBOM, Monitoring (a.k.a. Threat Intelligence), Software Updates
COMING SOON
BOLTING ON SECURITY:
Is there anything that can be done if I already have a design?
COMING SOON
BG Networks Cybersecurity Services & Training for Premarket Submissions
BG Networks offers a complete assortment of services and training options for Secure Product Develop Framework (SPFD) implementations. For more information on our SPDF training and services see our System & Services page.
Our Webinar Partners
BG Networks has partnered with companies who are experts in complementary areas of cybersecurity and bring in depth knowledge to this series of webinars. Our partners include
Cybersecurity Services
ICS supports our customers with software development, user experience design, platform and regulatory support to build next generation products. ICS provides a number of services focused on the medtech space including human factors engineering with a 62366 compliant process, hazard and risk analysis, 62304 compliant software development, and platform support including cybersecurity.
Trusted Execution Environments
Trustonic Secure Platform provides a certified solution for the storage and management of security or privacy sensitive data. This can be used to protect cryptographic keys and patient information ensuring devices use best in class security. It can also be used to provide defense in depth to protect other systems, such as secure communications or intrusion detection, and enable secure manufacture and tracking of devices throughout their lifecycle.
Risk Management
INTEGRITY Security Services (ISS) is a wholly owned subsidiary of Green Hills Software LLC., established to provide best practice embedded security products and services for the protection of smart devices in all industries from cyber security attacks. ISS's experience enables them to provide the world’s first Secure Platform for Medical (SPM) which dramatically reduces time and resources for medical device OEMs to meet Omnibus Act Section 3305 and FD & C Section 524B.
White Paper - Practical Advice for FDA Submissions
Off-The-Shelf Secure Product Development Framework
BG Networks offers a complete Secure Product Development Framework package to help you prepare a FDA premarket submission in the shortest possible time while providing a high level of confidence of a FDA acceptance by avoiding costly and time consuming deficiency letters.
For more information on our Medical Device SPDF Documentation Package, see our SPDF product page at the link below.
