With connected devices, telehealth, and remote patient monitoring becoming more widely used, there is an increasing risk of cybersecurity threats. Managing these vulnerabilities can be challenging. It is crucial for device manufacturers, clinicians, hospitals, and testing organizations to work collaboratively to create a safe and interoperable health care environment. The development of standards and adherence to an industry adopted conformity assessment program can help reduce these risks and demonstrate the product’s adheres to guidelines.

The IEEE Medical Device Cybersecurity Certification Program has been developed by the IEEE 2621 Conformity Assessment Committee (CAC), composed of stakeholders such as manufacturers, clinicians, regulatory agencies, test laboratories, cybersecurity solutions providers, and industry associations from around the world. 

This webinar will provide an overview of the program including the evaluation process, definition of scope and test requirements specific to medical devices; and the advantages over other programs:

• Pre-assessment of your medical device by an IEEE authorized lab
• Testing using IEEE 2621 Test Plan and Checklists that remove ambiguity from the process
• Standardized report on testing results 
• IEEE Certification Mark that helps manufacturers differentiate their products from competitors
• Certified products to be included in the IEEE Medical Device Registry
• Assistance with submission to regulatory bodies
• Helps meets FDA submission criteria

AGENDA

• Preparing Medical Device for FDA Submission
  • Naomi Schwartz, Sr. Director, MedCrypt
• IEEE Medical Devices Cybersecurity Program
  • Ted Osinski, Program Manager, ICAP Conformity Assessment, IEEE SA
  • Ron Starman, IEEE Cybersecurity Expert and Auditor
•  AAMI TIR 57 Standard
  
  • Michael Seeberger, Medical Device Senior Manager, Boston Scientific
• IEEE Authorized Test Laboratory
  • Rasma Araby, CEO of Atsec
•  Closing Remarks
  • Q&A

SPEAKERS

JOIN THE COMMITTEE

IEEE Medical Device Cybersecurity Certification Committee

The certification program is being developed by the Conformity Assessment Committee, which is comprised of broad range of stakeholders, that will benefit users, manufacturers, clinicians, regulators, payers, and other potential beneficiaries. Find out more about the committee and it's objectives, how you can contribute and sign up. 

Join now to get early access to test plans, voting rights, networking opportunities and early mover advantage.

SUPPORTERS

© Copyright 2024 IEEE – All rights reserved. Use of this website signifies your agreement to the IEEE Terms and Conditions.
A not-for-profit organization, IEEE is the world’s largest technical professional organization dedicated to advancing technology for the benefit of humanity.