Day

August 6, 2009
Company: Welch Allyn Protocol, IncDate of Enforcement Report 8/5/2009 Class:ll PRODUCT Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”), Recall # Z-1656-2009 REASON Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing...
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Company: Philips HealthcareDate of Enforcement Report 8/5/2009 Class:ll PRODUCT Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management, Recall # Z-1654-2009 REASON Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders’ original schedule time, ICIP can create a second instance of the same...
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Company: Hitachi Medical Corporation.Date of Enforcement Report 8/5/2009 Class:ll PRODUCT 1) Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less, Recall # Z-1651-2009; 2) Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version 2.11 or less, Recall # Z-1652-2009 REASON Incorrect scale on image: A software error can occur if two (2) different Field-of-View...
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SoftwareCPR Training Courses:

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:  June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person.  These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

 

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 


 

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
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
  • Southern Central Northeastern Pacific: 24-26 February 2025
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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

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