Day

August 14, 2019
Company: Philips North America, LLC Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Lantis 6.1 Commander, Model # 5493072 – Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Ingenuity CT, Model # 728326, computed tomography x-ray system Recall Number: Z-2186-2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system Recall Number: Z-2187-2019 Ingenuity Core Model # 728321, computed tomography x-ray system Recall Number: Z-2188-2019 iCT, Model # 728306, computed...
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Company: Ortho Clinical Diagnostics Date of Enforcement Report: 8/14/2019 Class II PRODUCT VITROS 250 Chemistry System, clinical chemistry analyzer Recall Number: Z-2174-2019 Recall Number: Z-2175-2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Recall Number: Z-2176-2019 VITROS 350 Chemistry System, clinical chemistry analyzer Recall Number: Z-2177-2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 8/14/2019 Class II PRODUCT The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,”* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a...
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Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT ORTHO VISION Analyzer for ID-MTS Gel Cards (ORTHO VISION), Software Version 5.12.3 and 5.12.4, Product Code: 6904577 Recall Number: B-0800-2019 ORTHO VISION Max Analyzer for ID-MTS Gel Cards (ORTHO VISION Max), Software Version 5.12.3 and 5.12.4, Product Code: 6904576 B-0801-2019 REASON Ortho...
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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:

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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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