Events & Speaking Engagements
About MedSec
Software as a Medical Device (SaMD)
RAPS Virtual Training
February 21, 2023
MedSec Involvement
Training Co-Instructor
Michelle Jump
Chief Executive Officer
Pat Baird
Regulatory Head of Global Software Standards, Philips
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.
Cybersecurity Unauthorized
RAPS Virtual Training
February 7 - 8, 2023
MedSec Involvement
Training Co-Instructor
Michelle Jump
Chief Executive Officer
Matthew Hazelett
Cybersecurity Policy Analyst, FDA
This 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 expectations. Technical staff will benefit from better understanding of how to translate regulatory expectations into concrete design and development activities. Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.
Linda Ricci
Director, Division of All Hazard Response, Science and Strategic Partnerships, FDA
Top Ten Highlights from FDA's Premarket Cybersecurity Guidance
Webinar
December 16, 2022
MedSec Involvement
Host
Michelle Jump
Chief Executive Officer
MedSec Webinar
Come join MedSec to learn perspectives from our new CEO, Michelle Jump, on the Top Ten issues that medical device professionals should be prepared for. Michelle's comments will focus on the impact of the US FDA's premarket draft medical device cybersecurity guidance. This presentation will review notable expectations in FDA's guidance and identify those elements that are currently recommended for inclusion in an FDA submission.
Lessons Learned from Palocity's Ongoing Journey into DevSecOps
Presentation During AdvaMed's Cybersecurity Summit
December 12, 2022
MedSec Involvement
Co-Presenter
Michelle Jump
Chief Executive Officer
AdvaMed Summit Presentation
Paylocity's Application Security Manager, Bruce Parr brings his unique perspective on cybersecurity to “Lessons Learned from Paylocity’s Ongoing Journey into DevSecOps”. This wide-ranging discussion will also feature one of MedTech’s prominent thought leaders on cybersecurity, MedSec's CEO, Michelle Jump. The program will be moderated by Orthogonal's Chief Solutions Officer, Randy Horton. This AdvaMed Cybersecurity Summit session is sponsored by Orthogonal.
December 6-8, 2022
MedSec Involvement
Booth
Michelle Jump
Chief Executive Officer
Scott Hanson
Director of Medical Device Security and Education
H-ISAC Summit
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.
Garrett Sipple
Vice President of Security Services
H-ISAC
Fall Americas Summit
Conference
CyberMed
Conference
November 18-19, 2022
MedSec Involvement
Attendee
Michelle Jump
Chief Executive Officer
Scott Hanson
Director of Medical Device Security and Education
CyberMed Summit is a two-day event focused on strengthening the preparedness and resiliency of our critical health infrastructure and medical devices against the persistent threat of cyber disaster events. With a special focus on our healthcare delivery organization, emergency management, and disaster response stakeholders, this event will feature insight from national thought leaders, physician specialists, and disaster and cybersecurity experts in addition to CyberMed’s hallmark clinical simulations, table top exercises, and workshops.
MD&M
Conference
November 2-3, 2022
MedSec Involvement
Presenting
Michelle Jump
Chief Executive Officer
Scott Hanson
Director of Medical Device Security and Education
The two-day educational event brings together medical manufacturers, industry experts, thought leaders, and academics to solve challenges in medical technology. including digital health, robotics, 3D printing and additive manufacturing, treatment of cardiovascular disease, and more.
AdvaMed
Conference
October 24-26, 2022
MedSec Involvement
Attendee
Michelle Jump
Chief Executive Officer
The MedTech Conference brings the top executives and innovators from across the world (the industry ) together to explore critical topics, share visions for the future - and build them, together.
TOPRA
Conference
October 18-20, 2022
MedSec Involvement
Panel
Michelle Jump
Chief Executive Officer
The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and the clinical requirements.
RAPS Marathon Training
Training
October 10 - 14, 2022
MedSec Involvement
Training
Michelle Jump
Chief Executive Officer
Matthew Hazelett
Cybersecurity Policy Analyst, FDA
Linda Ricci
Director, Division of All Hazard Response, Science and Strategic Partnerships, FDA
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 expectations.
RAPS Convergence
Conference
September 11 - 13, 2022
Michelle Jump
Chief Executive Officer
MedSec Involvement
Booth
Scott Hanson
Director of Medical Device Security and Education
RAPS Convergence is the largest and most well-recognized annual gathering of regulatory professionals, scientists, and innovators in the world.
FDA and MedSec: Threat Modeling Perspectives Based on 2022 Draft Premarket Guidance
Webinar
May 20, 2022 11 a.m. - 1:00 p.m. ET
MedSec Involvement
Host
Matthew Hazelett
Cybersecurity Policy Analyst
FDA
Scott Hanson
Director of Medical Device Security and Education
Michelle Jump
Chief Executive Officer
FDA Cybersecurity Policy Analyst, Matthew Hazelett, joins MedSec Chief Regulatory Strategist, Michelle Jump, and MedSec Global Regulatory Advisor, Scott Hanson, for this webinar discussing the threat modeling expectations and guidance.