Day

January 19, 2011
Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX. The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and...
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Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is...
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Company: Bunnell Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Rx Only. Recall # Z-0901-2011; 2) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Rx Only. Recall # Z-0902-2011 REASON Product software coding error may compromise patient safety. RECALLING FIRM/MANUFACTURER Bunnell, Inc.,...
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Company: McKesson Provider Technologies .Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and...
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Company: GE Healthcare.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) HiSpeed LXI (2200997). Recall # Z-0744-2011; 2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011; 3) HiSpeed DX/I (2201000). Z-0746-2011; 4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011; 5) HiSpeed DX/I (2249696). Recall # Z-0768-2011; 6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011; 7) HiSpeed FX/I (2200997 with...
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Company: C. R. Bard Inc.Date of Enforcement Report 1/19/2011 Class lll: PRODUCT Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter. Recall # Z-0719-2011 REASON Error can occur...
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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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