Nov

2010

$Draft 80001-2-x Communication of Security Needs$

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A new work item and draft technical report for guidance in implementing IEC 80001-1:2010. This TR provides a framework for a dialogue between a medical device manufacturer and a hospital regarding system and data security controls. The report is at the link provided until the review period ends on 24-Feb-2011.

IEC 80001-2-x: Guidance for the communication of medical device . . .

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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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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

$Draft 80001-2-x Communication of Security Needs$

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