On-demand courses address the changes in regulatory compliance and guidance on secure device design, development, manufacturing, and postmarket surveillance
HOUSTON – April 11, 2023 – Velentium, a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices, today announced the launch of three online cybersecurity courses designed for medical device developers and executives. These trainings address many of the ever-changing elements impacting the medical device industry including new FDA and regulatory guidance, secure product lifecycle management, device security and design, vulnerability assessments, secure development and manufacturing, cybersecurity testing and documentation, and postmarket surveillance.
The new courses from Velentium are based on the bestselling engineering textbook Medical Device Cybersecurity for Engineers and Manufacturers and are taught by one of its principal authors, Christopher Gates. Christopher Gates has been developing and securing medical devices for industry-leading manufacturers for over 50 years. He frequently collaborates with regulatory and standards bodies to define and codify tools, techniques, and processes that enable the creation of secure medical devices.
“The Medical device industry changes frequently and there are now more hoops to jump through before a product can go to market, particularly on the regulatory and technical front. All device submissions are required to have a cybersecurity plan in order to be considered for approval, and it’s imperative that designers stay current on all the latest FDA guidelines, security, design, development and manufacturing and postmarket surveillance,” said Christopher Gates, Director of Product Security at Velentium. “We designed these embedded cybersecurity courses for medical device designers after we saw a gap in many of the trainings available. Instead of solely focusing on IT and network cybersecurity, we wanted to provide trainings that addresses the design of the device itself to be secure. Embedded cybersecurity experts are in high demand. Our goal is for every participant to gain the tools to help close the skills gap, leading to more approved submissions and fewer recalls.”
Velentium and Gates have created three separate trainings:
- Mastering Embedded Cybersecurity
- A 60-hour masterclass including a certification exam. The course instructs and certifies for competence in embedded cybersecurity.
- Embedded Cybersecurity for Everyone
- An 8-hour course with no exam. This state-of-the-art presentation series brings individual contributors and project managers up-to-speed on secure product development.
- Executive Briefing
- A 2-hour executive briefing for key leaders & top decision makers in the medical device space.
Mastering Embedded Cybersecurity
Mastering Embedded Cybersecurity is a 60-hour remote-learning course on medical device cybersecurity. This course instructs and certifies for competency in embedded cybersecurity and contains assessments required for certifications and continuing education for annual recertification. By completing the masterclass, attendees will receive 12 months of access to the complete set of training videos and course content, 12 months of access to virtual office hours for live Q&A with the instructor each week (renews with enrollment in continuing education), as well as lifetime access to a dedicated Slack workspace where attendees and alumni can post and answer questions, read breaking news and network with peers in the embedded cybersecurity community.
This masterclass is designed for students and technical professionals in the following roles: hardware engineers, systems engineers, technical managers and directors, software engineers and developers, mobile and cloud engineers and developers and firmware engineers and developers. The course is available on-demand and designed to be completed at your own pace. Upon completion of the program, a professional certification will be granted.
The baseline cost for the masterclass is $7,995 per person for the first year, with an optional $1,495 per year for continuing education to maintain the certification.
Embedded Cybersecurity for Everyone
Embedded Cybersecurity for Everyone is an 8-hour remote-learning course on medical device cybersecurity. This course lays out the high-level topics of secure product development for level-setting product security expectations, protecting business models, advancing market position, and equips managers and teams to drive the integration of embedded cybersecurity best practices into their company’s current operations. By completing this course, attendees will receive 12 months of access to the complete set of training videos and course content, 12 months of access to virtual office hours for live Q&A with the instructor each week (renews with enrollment in continuing education), as well as lifetime access to a dedicated Slack workspace where attendees and alumni can post and answer questions, read breaking news and network with peers in the embedded cybersecurity community.
Embedded Cybersecurity for Everyone is designed to bring non-technical personnel up to a baseline level of awareness and general knowledge of cybersecurity for medical devices. The course is designed for non-technical personnel across a variety of roles, including senior leadership, project and program managers, regulator and quality personnel, and those that work in the medical device design, development and manufacturing sectors.
The baseline cost for the course is $995 with volume discounts available. The course is available on-demand and designed to be completed at your own pace. Upon completion of the program, a professional certification will be granted.
Alert
Alert is a 2-hour state-of-the-art executive briefing series on medical device cybersecurity. Alert is designed for senior leadership, board members, c-suite, officers and directors and brings a baseline level of awareness and general knowledge of cybersecurity for medical devices.
Alert lays out the high-level topics of secure product development for protecting business models, advancing market position and driving the integration of embedded cybersecurity best practices into current operations. By completing this course, attendees will receive 1 month of access to the complete set of training videos and course content, 3 months of access to virtual office hours for live Q&A with the instructor each week, and lifetime access to a dedicated Slack workspace where attendees and alumni can post and answer questions, read breaking news, and network with peers in the embedded cybersecurity community.
The cost for the executive briefing is $4,995 for up to 12 attendees.
Attendees who have completed any of the courses will also have occasional opportunities to purchase additional modules briefing them on significant updates and changes, including platform and technology changes, regulatory changes, new resources available and changes in the threat landscape.
Interest signups for Mastering Embedded Cybersecurity, Embedded Cybersecurity for Everyone and Alert became available on April 1, 2023. To learn more about these courses, or to submit an application, visit Velentium's website.
About Velentium
Velentium is a Houston-based professional engineering firm specializing in the end-to-end design, development, manufacturing and post-market support of therapeutic and diagnostic active medical devices. The company's core competencies include active implantable medical devices, systems engineering, firmware & software, cybersecurity, mobile & cloud, electrical & mechanical engineering, human factors & usability, automated test systems, and CGMP manufacturing. With customers all over the world, Velentium has experience working with all sizes of clients, ranging from startups seeking seed funding to established Fortune 500 companies.
