June 12, 2019
Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 6/12/2019 Class III PRODUCT 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 – Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Recall Number: Z-1699-2019 REASON Power Logic Board Fail Message on the...
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Company: Philips North America, LLC Date of Enforcement Report: 6/12/2019 Class II PRODUCT IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 – Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected...
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Company: Flowonix Medical Inc Date of Enforcement Report: 6/12/2019 Class II PRODUCT Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Recall Number: Z-1712-2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
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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 5-7, 2024
Boston, MA

Email 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: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

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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