26

Jul

2017

TIP: Cybersecurity and Risk Control

80002-1, cybersecurity, risk

0

Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®:

Cybersecurity vulnerabilities can have unpredictable effects on safety. Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar. That concept is explained in relation to common cause/indirect software failures (as in AAMI TIR-32 and IEC/TR 80002-1). Therefore, it is usually advantageous to identify vulnerabilities (not threats; those are harder for a manufacturer to identify) and apply controls rather than focus on probability estimation. Treat cybersecurity vulnerabilities like common cause software failures while thinking about realistic scenarios and simple mitigation, the evaluating of the mitigations seems sufficient – given the overall risk of the device based on its intended use, and the role of the potentially affected software in the device is generally a useful approach.

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!

Agile principles that align well with medical
Backlog management
Agile risk management
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

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

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

Next public offering: TBD

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Registration Link:

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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