TIP: Cybersecurity and Risk Control

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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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