Day

October 26, 2005
Company: Misys Healthcare Systems.Date of Enforcement Report: 9/29/2005 Class:II PRODUCT Misys Laboratory version 6.1 – Microbiology Module, Recall # Z-0088-06 REASON Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000 the system will file the number 100 instead of number 100,000. CODE All...
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/docs/GlucoseMeterFDASafetyAlert102605.pdf
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Company: Baxter Healthcare Corp.Date of Enforcement Report: 10/26/2005 Class:II PRODUCT Baxter’s Patient Care System (BPCS) software, Pharmacy Management – Inpatient – product code 2M5013 and Point of Care – product code 2M5014; made in Canada, Recall # Z-0061-06 REASON If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached...
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Company: Abbott Diabetes Care, Inc..Date of Enforcement Report: 6/7/05 Class:I PRODUCT Abbott Diabetes Care, Inc. Blood Glucose Meters REASON The recalled Abbott blood glucose meters can inadvertently switch the glucose readings from mg/dL, the U.S. standard to mmol/L, the foreign standard. The unit of measure could change in the course of setting the time and...
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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.

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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

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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)

Next public offering:  TBD

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