Day

May 11, 2007
Company:Toshiba American Med Sys Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Recall # Z-0771-2007 REASON Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature...
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Company:Instrumentation Laboratory Co., Lexington, MA, Date of Enforcement Report:5/9/2007 Class:ll PRODUCT GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007 REASON Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result. CODE Serial numbers prior to 07020343 with Software versions prior to V1.1.3 RECALLING FIRM/MANUFACTURER...
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Company:bioMerieux, Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT a) BacT/ALERT Classic System Software, Blood Culturing System, Recall # Z-0773-2007; b) BacT/ALERT 3D System Software, Blood Culturing System, Recall # Z-0774-2007; c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System, Recall # Z-0775-2007; d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System, Recall # Z-0776-2007 REASON...
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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:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

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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