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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.


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