Day

May 9, 2024
Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: May 06, 2024 Class I PRODUCT t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology version 2.7 or later /UDI: 00850006613274 Recall Number: Z-1609-2024 REASON: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 5/9/2024 Class I PRODUCT Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Recall Number: Z-1776-2024 REASON: Due to a software issue, there is the potential for...
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WARNING LETTER CMS# 675673 Cue Health, Inc. San Diego, CA May 9, 2024 Inspection Dates: on 10 dates between October 17, 2023 and November 3, 2023. Inspection Issue(s): “not complying with the following Conditions of Authorization in the Letters of Authorization for EUA200248 and EUA210180. For example: Evidence obtained during the inspection demonstrated that your...
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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: TBD

 


 

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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