Mar

2019

FDA Safety Communication on Software Update for Cardioverter Defibrillator failure

In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service – Message Code 102” is displayed on the screen, users have been advised to contact Zoll immediately for a replacement. A software update has been replaced that includes a more prominent warning to immediately contact Zoll should that message code appear. The full safety communication can be viewed at

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632783.htm?utm_campaign=LifeVest%204000%20Wearable%20Cardioverter%20Defibrillator%20by%20Zoll%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua

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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

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.

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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)

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FDA Safety Communication on Software Update for Cardioverter Defibrillator failure

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