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Fundamental Series

Part of MedSec Academy

The Fundamentals Series of courses help bring cybersecurity awareness to less experienced staff in cybersecurity or cybersecurity practitioners moving into the medical device regulatory environment.

Course 001 FDA Cybersecurity Submissions: Understanding the Documentation Requirements

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Description: This course will go into detailed overviews of the 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 when the deliverables should be generated.

 

Audience: This course is best suited to those who already have awareness of medical device cybersecurity and are interested in a more detailed understanding of FDA deliverables and when to generate them. This may include software engineers, cybersecurity staff, regulatory affairs staff, and management.

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Planned Agenda:

  1. What is Cybersecurity?

  2. Importance of Cybersecurity for Medical Devices

  3. Regulation of Cybersecurity – US Focus

  4. Cybersecurity in Design

  5. Postmarket Responsibilities

Course 001

Course 002 • Understanding Your New Sandbox: Preparing Cybersecurity Professionals for the Medical Device Space

 

​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.

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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.

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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

Course 002

Course 003  International Cybersecurity Regulations—Non-US

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Description: The US FDA has been a strong driver of medical device security expectations, but they are not the only regulators outlining medical device cybersecurity expectations. This course will review the specific medical device cybersecurity requirements for countries outside of the US, including common threads amongst the countries.

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Audience: This course is best suited for staff who are responsible for navigating cybersecurity expectations outside the US, either to maintain marketed products or to enter into a market for the first time.

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Planned Agenda:

  1. Common threads across the globe

  2. IMDRF: Driving harmonization in thought and policy

  3. Big hitters: European Union, Japan, Australia, Canada, China

  4. Other markets to consider

Course 003

Course 004 Cybersecurity Standards for Medical Devices

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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.

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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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Planned Agenda:

  1. How are cybersecurity standards used in the medical device industry

  2. Medical device specific cybersecurity standards: domestic and international

  3. General cybersecurity standards and their use

  4. Non-standards for cybersecurity such as NIST

  5. Useful standards from other industries such as industrial control standards

Course 004
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