Events & Speaking Engagements
About MedSec
RAPS Convergence 2023 - Montreal
Medical Device Cybersecurity: Planning a Global Strategy
Date: October 3-5, 2023
MedSec Involvement: Speaker
Michelle Jump
Chief Executive Officer, MedSec
Suzanne Schwartz
Director of the Office of Strategic Partnerships and Technology Innovation, FDA
Description: RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy.
RAPS Virtual Workshop
Software as a Medical Device (SaMD)
Date: June 14-15, 2023
MedSec Involvement: Training Co-Instructor
Michelle Jump
Chief Executive Officer, MedSec
Pat Baird
Regulatory Head of Global Software Standards, Philips
Description: Navigating the regulatory expectations for software-based products is particularly challenging and requires a different approach. Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD). Our expert faculty will address both how to determine when software is categorized as an SaMD and how to correctly classify it under global requirements. Given that assessing risk for software is more challenging, attendees will use case studies to help them complete required evaluations.
Webinar
Understanding SBOMs: What Every Medical Device Manufacturer Needs to Know!
Date: June 9, 2023
MedSec Involvement - Host
Michelle Jump
Chief Executive Officer, MedSec
Buddy Smith
Director of Technical Consulting
Description: The 2023 Omnibus Appropriations Bill led to update to Section 524B of the FD&C Act, including requirements for current FDA submissions for Software Bills of Material (SBOMs). That means that SBOMs are now required for FDA submissions. Join MedSec expert, Michelle Jump who has been involved with this effort since 2018, leading a task group for the NTIA SBOM initiative and MedSec’s technical expert Buddy Smith as they walk through the basics for SBOM structure, maintenance, distribution as well as the technical challenges of managing SBOMs.
Webinar
Understanding SBOMs: What Every Medical Device Manufacturer Needs to Know!
Date: June 8, 2023
MedSec Involvement - Host
Michelle Jump
Chief Executive Officer, MedSec
Buddy Smith
Director of Technical Consulting
Description: The 2023 Omnibus Appropriations Bill led to update to Section 524B of the FD&C Act, including requirements for current FDA submissions for Software Bills of Material (SBOMs). That means that SBOMs are now required for FDA submissions. Join MedSec expert, Michelle Jump who has been involved with this effort since 2018, leading a task group for the NTIA SBOM initiative and MedSec’s technical expert Buddy Smith as they walk through the basics for SBOM structure, maintenance, distribution as well as the technical challenges of managing SBOMs.
Webinar
Bluetooth Low Energy for Connected Medical Devices
Solving Communication Challenges on the Mobile Side
Date: May 24, 2023
MedSec Involvement - Co-Host with Orthogonal
Bernhard Kappe
CEO and Founder, Orthogonal
Presenter
Buddy Smith
Director of Technical Consulting, MedSec
Panel Member
Randy Horton
Chief Solutions Officer, Orthogonal
Moderator
Description: Medical device developers, manufacturers and R&D groups have experience implementing Bluetooth Low Energy (BLE) on the firmware side, where everything is under your control. But architecting BLE for the mobile side, where control rests firmly in the smartphone’s OS, is far more challenging. To arrive at the right solutions, you need the right understanding of the inherent complexities of mobile BLE connectivity. Join Orthogonal and MedSec for a webinar crash course on BLE for connected medical devices: The challenges of device to phone communication, how to visualize those challenges and how to solve them while keeping product deadlines and budgets in check.
Encore Webinar
Planning for Omnibus: New FDA RTA Guidance
Date: May 24, 2023
MedSec Involvement - Host
Michelle Jump
Chief Executive Officer, MedSec
Charles Farlow, CISSP
Senior Director, Program Management and Regulatory Policy, MedSec
Description: Come join MedSec’s free webinar on the Omnibus Act, presented by CEO, Michelle Jump, and Senior Director, Chuck Farlow. Michelle and Chuck will be sharing their insights on significant new cybersecurity requirements that medical device manufacturers will need to meet due to recent passage of the 2023 Omnibus Appropriations bill. Section 3305 requirements include SBOMs, coordinated vulnerability disclosure, and providing customers with postmarket updates and patches to their devices. Michelle and Chuck will also provide commentary addressing FDA's March 2023 Guidance on its Refuse to Accept Policy for Cyber Devices and Related Systems. This is an encore round of a previous MedSec webinar on this topic. This one is scheduled to be more compatible for an audience in the European Union.
RAPS Euro Presentation
Medical Device Cybersecurity: Compliantly Securing our Healthcare Future
Date: May 12, 2023
MedSec Involvement: Presenter
Michelle Jump
Chief Executive Officer, MedSec
Description: Cybersecurity has gained increased focus across many global regulatory jurisdictions, including the United States (US), European Union (EU), Australia, Canada, Asia, and others. In the past year, the regulatory expectations have moved from foundational expectations to true technical rigor and specificity. This lecture will review not only the written expectations of key jurisdictions but also the "unwritten" expectations. The goalpost for what sufficient regulatory documentation is needed to meet regulatory expectations has shifted and this session will review the most critical areas to focus on to meet cybersecurity expectations, including security risk management, threat modeling, security-specific labeling, and postmarket security plans.
Conference
RAPS Euro Convergence
Date: May 10-12, 2023
MedSec Involvement - Booth
Michelle Jump
Chief Executive Officer, MedSec
Catherine Lowe
Director, Quality and Regulatory, MedSec
Description: RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest developments in healthcare products in Europe and beyond—medical devices, IVDs, pharmaceuticals, and combination products. Gather with European and global regulatory professionals to discover methods that professionals and industries can harmonise through regulatory confluence.
Conference
H-ISAC Spring Americas Summit
Date: May 9-11, 2023
MedSec Involvement - Booth
Garrett Sipple
Chief Operating Officer, MedSec
Jim Keller
Vice President, Marketing and Business Development
Scott Hanson
Director, Medical Device Security and Education
Description: Health-ISAC Inc. (H-ISAC, Health Information Sharing and Analysis Center), is a global, non-profit, member-driven organization offering healthcare stakeholders a trusted community and forum for coordinating, collaborating and sharing vital physical and cyber threat intelligence and best practices with each other.
Webinar
Planning for Omnibus: New FDA RTA Guidance
Date: April 28, 2023
MedSec Involvement - Host
Michelle Jump
Chief Executive Officer, MedSec
Charles Farlow, CISSP
Senior Director, Program Management and Regulatory Policy, MedSec
Description: Come join MedSec’s free webinar on the Omnibus Act, presented by CEO, Michelle Jump, and Senior Director, Chuck Farlow. Michelle and Chuck will be sharing their insights on significant new cybersecurity requirements that medical device manufacturers will need to meet due to recent passage of the 2023 Omnibus Appropriations bill. Section 3305 requirements include SBOMs, coordinated vulnerability disclosure, and providing customers with postmarket updates and patches to their devices. This webinar is an encore round from a previous MedSec webinar, with additional commentary addressing FDA's March 2023 Guidance on its Refuse to Accept Policy for Cyber Devices and Related Systems.
RAPS In-Person Workshop
Cybersecurity Unauthorized
Date: April 20-21, 2023
MedSec Involvement - Workshop Co-Instructor
Michelle Jump
Chief Executive Officer, MedSec
Matthew Hazelett
Cybersecurity Policy Analyst FDA
Linda Ricci
Director, Division of All Hazard Response, Science and Strategic Partnerships, FDA
Description: This interactive, in-person workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity. Technical staff will get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators while also teaching them how to establish trust with customers concerned about risk related to medical devices on their networks.
RAPS In-Person Workshop
Software as a Medical Device (SaMD)
Date: April 18-19, 2023
MedSec Involvement: Training Co-Instructor
Michelle Jump
Chief Executive Officer, MedSec
Pat Baird
Regulatory Head of Global Software Standards, Philips
Description: In this two-day, in-person workshop, regulatory experts will explore the current and evolving global regulatory requirements affecting SaMD, how to determine when software is considered regulated as SaMD and how to determine the correct class/classifications under global requirements. Attendees will learn how to address the numerous challenges in performing risk management/assessment for software by completing required evaluations using practical case studies.