Events & Speaking Engagements

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• Presenter - Michelle Jump - Chief Executive Officer

• Date: December 10, 2024 

• Time: 9:00 AM to 3:00 PM each day (Eastern Time)

• Location: Online

Description: Standards are the backbone of any regulated industry. In some cases, they are mandatory, such as IEC 81001-5-1 in Japan. In other cases, they can be leveraged to develop processes that align with regulators’ thinking, such as AAMI TIR 57 in the US. Whatever the driver, standards help you build process and products faster and with a higher chance of success with regulators and customers. This course will review not only the content of key cybersecurity standards but also how to strategically use them.

Audience: This course is best suited for those seeking a better understanding of how to use cybersecurity standards in the medical device industry.

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• Presenter: Matt Hazelett - Chief Regulatory Officer

• Date: December 11-13 

• Time: 9:00 AM to 1:00 PM each day (Eastern Time)

• Location: Online

Description: This course will go into more detailed overviews of the processes and deliverables needed for medical device cybersecurity throughout the total product lifecycle. It will help ensure your organization is aware of how to meet regulatory requirements for submissions and the processes to have in place and follow to prepare for inspections.

Audience: This course is best suited to those who already have awareness of medical device cybersecurity and are interested in a more detailed overview of how to manage medical device cybersecurity over the total product lifecycle. This may include software engineers, cybersecurity staff, regulatory affairs staff, and management.

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• Presenter - Michelle Jump - Chief Executive Officer

• Presenter - Matt Hazelett - Chief Regulatory Officer

• Date: January 21 and 23 

• Time: 9:00 AM to 1:00 PM each day (Eastern Time)

• Location: Online

Description: The need for top security talent in the medical device industry far exceeds the currently available pool. That means that we often welcome those outside of the industry to fill those seats. This can be a challenge both for the new hire as well as the team that they join. Working in such a highly regulated industry brings many rules that can seem both onerous and confusing. MedSec would like to help. This course is built to connect classic cybersecurity knowledge around the framework of the compliance considerations of working in the medical device industry.

Audience: This course is best suited for technical staff whose careers have not historically been in the medical device industry and would benefit from a better understanding of the regulations and best practices.

Planned Agenda:

1. Medical Device 101: How to navigate regulated space

2. Importance of documentation and process

3. Moving fast and making progress in a regulated environment

4. Pitfalls to avoid

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• Presenter: Michelle Jump - Chief Executive Officer

• Presenter: Matt Hazelett - Chief Regulatory Officer

• Date: January 29, 2024

• Time: 9:00 AM to 5:00 PM each day (Eastern Time)

• Location: Online

Description: This course goes “under the hood” of all things medical device cybersecurity including creating documentation for cybersecurity within your quality management systems, current standards, and design.

Audience: This is for medical device cybersecurity team members and regulatory affairs personnel who are looking to set up their organizations for success moving forward and who already have general familiarity with the basics for cybersecurity submissions.

Planned Agenda - Advanced Fundamentals 201

1. Why does this feel so difficult, so fast?

2. Concepts and Challenges

3. Generating submission-ready eSTAR documents from your QMS

4. Overview of cybersecurity standards and their use

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Jan 30, 2025 11:00 AM in EST

Description: With the heightened speed of technological innovation and the substantial increase in medical device connectivity combined with the seemingly unending emergence of cyber threats, the US Government is taking a crucial legislative stance and advancing towards modernizing cybersecurity regulations for connected medical devices. Congress introduced premarket cybersecurity requirements into US legislation in late 2022 via the Omnibus Act and the FDA has begun to fulfill its directive under this Act by finalizing premarket cybersecurity guidance for connected devices and updating the eSTAR submission template. Navigating these regulatory advancements can pose a notable challenge for medical device manufacturers.   

In this panel session, we will outline the FDA’s cybersecurity submission expectations and discuss strategies to help ensure a successful submission.  Additionally, experts will share insights on industry best practices for implementing robust cybersecurity measures within the development and lifecycle management of medical devices to cultivate the right cybersecurity submission deliverables. Attendees will have the opportunity to engage in a Q&A session to address specific concerns and to implement any insights they gain directly into their own organization.

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Feb 27, 2025 1:00 PM in EST

With Matt Hazelette, Chief Regulatory Officer

Description: One of the most challenging and new documentation deliverables in the 2023 FDA Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” are the Architecture Views. These Architecture Views are frequent deficiencies from the FDA in premarket submissions and can be challenging to create late in the development process or during a deficiency hold.  

In this webinar, we will break down what the Architecture Views are, why FDA is asking for them, when to start developing them, and how to get started making them. Attendees will have the opportunity to engage in a Q&A session to address questions about the Architecture Views and approaches to drive success.