Day

August 10, 2016
Company: Philips Electronics North America Corporation Date of Enforcement Report 8/10/2016 Class lI: PRODUCT IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2301-2016 REASON Studies coming over via telmed were missing...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2303-2016 REASON A migrated...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge HEMO software Recall Number Z-2341-2016 REASON The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. Hartland, WI on 7/2/2012 Voluntary:...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures....
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The...
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Company: B-K Medical A/S. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT BK Medical ApS Ultrasound System Scanner bk2300 – Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The...
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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 with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Virtual, Live)

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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:

  • TBD
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)

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