Day

March 23, 2016
Company: CHG Hospital Beds Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading...
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Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.) Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.. Recall Number Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide...
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Company: Mckesson Medical Immaging Date of Enforcement Report 3/23/2016 Class lI: PRODUCT McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. Recall Number Z-1182-2016 REASON McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue...
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Company:Roche Diagnostics Operations, Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling...
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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:

Register Now

 


 

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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