Oct

2022

October – Cybersecurity Awareness Month

Since October is Cybersecurity Awareness Month, the US FDA released a new video to provide ideas and approaches for Healthcare Professionals (HCP) discuss and explain to patients, the concepts and methods for cybersecurity with regard to interconnected medical devices. The video titled, “xx,” is designed to promote, and perhaps facilitate, communication between HCPs and patients. See the video at this link: https://youtu.be/oxLbTPdtsLI

Other posts related to cybersecurity: New Cybersecurity Standard

About the author

Brian Pate

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD

October – Cybersecurity Awareness Month

Brian Pate

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