Presented as both an on-site event and as a virtual conference via web cast. 

About the Conference

Dealing with medical software security threats is a problem shared by hospitals and the medical technology manufacturing industry.  Designing products for updating and patching, identifying vulnerabilities, issuing and implementing patches, and responding to incidents require good communication and sharing of information.

This conference brings together leading experts from FDA, the medical device industry, hospitals, and independent consultants to share experiences and discuss strategies and best practices for designing and evaluating secure technologies and ensuring system and patient safety.

Topics include:

  • Hospital cybersecurity challenges
  • Device manufacturer security challenges
  • Designing secure devices that can be updated
  • Threat monitoring
  • Penetration testing
  • FDA expectations on cybersecurity and patching
  • Patching procedures and best practices
  • The function and benefits of ISAOs
  • Cybersecurity and liability
  • Vendor and technology evaluation

Who should attend:

  • Chief Technology Officers
  • Chief Information Security Officers
  • Medical technology software engineers
  • Regulatory affairs experts dealing with software
  • Software quality engineers
  • Compliance officers
  • Risk managers



Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.


  • Rick Brooks - Manager of Electrical, Software and Systems Engineering, Battelle
  • Seth Carmody - Cybersecurity Project Manager, CDRH
  • LCDR Cristina Dar  - Sr. Science Health Advisory, CDRH
  • Stephanie Domas - Vice-President of Research, MedSec
  • Sara Dyson - Assistant Vice-President, Loss Control, Medmarc 
  • Anura Fernando - Principal Engineer, Medical Systems Interoperability & Security, Underwriters Laboratories
  • Julian Goldman, MD - Medical Director, Partners HealthCare Biomedical Engineering; Director, Massachusetts General Hospital Medical Device Interoperability & Cybersecurity Program
  • Michelle Jump - Director, Regulatory Affairs Cybersecurity, Carestream
  • Robert Mai - Sr. Manager, Cyber Risk Services, Deloitte & Touche, LLP
  • Kevin McDonald - Director, Clinical Information Security, Mayo Clinic
  • Colin Morgan - Director, R&D & Product Security, Information Security & Risk Management, Johnson & Johnson 
  • Scott T. Nichols - Director, Global Product Privacy and Cybersecurity - R&D, Beckman
  • Shane Ryan - EVP, BSI Cybersecurity Information Resilience Group
  • Andrew Sargent - Director, Product Security, Monitoring & Analytics/Therapeutic Care, Philips Healthcare
  • Suzanne B. Schwartz, MD, MBA - Associate Director for Science and Strategic Partnerships, CDRH
  • Joseph P. Sener, PE - VP Quality, ICU Medical
  • Scott Shindledecker - Product Security Officer, Diagnostics, BD Life Sciences
  • Kevin M. Stoffell, CISSP-ISSAP - Cybersercurity Architect, Cyber Innovation Unit, Battelle Memorial Institute
  • Other Speakers to be announced

  • When

  • Tuesday, May 1, 2018 - Wednesday, May 2, 2018
    8:30 AM - 4:00 PM

  • Where

  • Hogan Lovells
    555 13th Street NW
    Washington, DC 20004

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