Day

August 2, 2017
Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 ClasslI: PRODUCT CS 300 Intra-Aortic Balloon Pump Recall Number Z-2738-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient...
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Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 Class lI: PRODUCT CS 100i Intra-Aortic Balloon Pump. Recall Number Z-2736-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a...
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Company:Beckman Coulter Inc.. Date of Enforcement Report 8/2/2017 Class lII: PRODUCT Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number B-0741-2017 REASON Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.. RECALLING FIRM/MANUFACTURER Bedkman Coulter, Brea, CA...
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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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