Day

January 18, 2017
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR checklist for “IEC 82304-1: Health software – Part 1: General requirements for product safety.”  Download: IEC 82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device...
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Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Ultimax DREX-ULT80, Model No. KXO-80XM Multipurpose digital x-ray system for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy Recall Number Z-1022-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an examination....
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Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Kalare DREX-KL80, Model No. KXO-80XD Diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations Recall Number Z-1021-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an...
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SoftwareCPR has posted its new checklist for “IEC 82304-1: Health software – Part 1: General requirements for product safety” in our website library and on our checklists page. This is free for our paid subscribers. SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 1/18/20176 Class lI: PRODUCT IQon Spectral CT with software version 4.7.0Product Usage:The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-1006-2017 REASON...
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Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. Recall Number Z-0987-2017 REASON Cross profile for Varian 60 degree wedge shows “horns.”...
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Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-1009-2017 REASON Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. RECALLING FIRM/MANUFACTURER Elekta inc., Atlanta, GA on 12/21/2016. Voluntary: Firm Initiated...
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Company:Varian Medical Systems, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan...
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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

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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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