Dual Presentation: Medical Device Cybersecurity Compliance

Program Speakers:  

Eric Henry, Sr. Quality Systems & Compliance Advisor, 

                        at Law firm King & Spalding, LLC.

35+ year veteran of technology, medical device, and legal industries with focus on software design control, serves on the AFDO/RAPS Healthcare Products Collaborative AI Strategic Committee (a FDA collaborative community), co-leads the AFDO/RAPS Good Machine Learning Practice Working Team, advises the Coalition for Health AI (CHAI)

And

Rajesh Kanungo, Founder and CEO of TalaSecure  

With over 25 years of experience in cybersecurity, specializing in medical devices, IoT systems, and critical infrastructure, has more than 42 patents, primarily in cybersecurity, possesses extensive expertise in AI/ML, generative AI, secure manufacturing, vulnerability modeling, and risk assessments.

 

Event Agenda:

DATE: Wednesday 5 March 2025

TIME: 6:00 –  6:05 PM Welcome and Announcements

6:05 –  6:10 PM Introduction to Eric Henry

6:10 –  7:05 PM       Presentation Topic: 

                                                   The defense of cybersecurity for medical devices

                                                   during inspections and submissions in light of

                                                   the latest regulatory literature

• • • • • • • • • • Questions to be explored:
                  • Why do (or should) companies concern themselves with cybersecurity during facility inspections and product submissions?
                  • How does the defense of cybersecurity relate to design controls?
                  • How does the defense of risk management relate to cybersecurity threat modeling and vulnerability assessment during an inspection?
                  • How can a company educate an FDA Investigator who is not a cybersecurity expert during an inspection?
                  • What is the current regulatory landscape for medical device cybersecurity?
                  • What are some differences and similarities in global cybersecurity regulatory requirements and guidance?

7:05 – 7:20 PM Q and A

7:20 – 7:25 PM Introduction to Rajesh Kanungo

7:25 –  7:45 PM       Presentation Topic: 

                                 The Engineering Robust Cybersecurity for Medical Devices: Bridging Innovation and Compliance

•                                                                 Key Discussion Points:       
  • • • • • • • • • • • • Understanding the FDA’s New Cybersecurity Guidelines
                        • Engineering Secure Medical Devices: A Hands-On 
                        • approach
                        • Case Studies in Action: Lessons from the Field
                        • Navigating Compliance from an Engineering Perspective
                        • Proactive Communication with Regulators
                        • Future Challenges and Opportunities

  7:45 – 8:00 PM Q and A (Both Speakers) and end                                              

 

LOCATION: This event is being offered only virtually. The zoom link will be shared with you via email 1-2 days before the event.

Registration Information:

• Register for the event here 

Contact 

[email protected] 

Pricing – Online – Registration (ends Tuesday, March 04, 2024)

 

 

Registrant Type	Event Price
Member	$10.00
Lifetime	$10.00
Non-Member	$20.00

 

 

Cancellation Policy

 

 

There will be no refunds for cancellations.