Day

September 21, 2016
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306 Recall Number Z-2799-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Recall Number Z-2798-2016 REASON There is a potential for the first and/or last name of one patient to be...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395 Recall Number Z-2803-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394 Recall Number Z-2802-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393 Recall Number Z-2801-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392 Recall Number Z-2800-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...
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Company: Hospira Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.. Recall Number Z-2790-2016 REASON...
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Company: Thermo Finnigan LLC. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Endura MR Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and...
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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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