Day

August 24, 2005
Company: Konica Medical Imaging, Inc,Date of Enforcement Report: 8/24/05 Class: III PRODUCT Regius-IM, The Regius Image Manager for Centralized workflow and improved image quality software, Recall # Z-1391-05 REASON One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three...
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Company: CepheidDate of Enforcement Report: 8/24/05 Class: II PRODUCT SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler, Recall # Z-1378-05 REASON A problem in the software has the potential to be associated with the incorrect reporting of sample results. CODE All units with software code version numbers: PN950-0101, Rev 1.7...
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Company: Beckman Coulter, IncDate of Enforcement Report: 8/24/05 Class: II PRODUCT Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05 REASON Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results. CODE Versions...
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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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