Guiding clients to effective and efficient compliance and regulatory approvals

Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 3/11/2024 Class II PRODUCT LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall Number: Z-1282-2024 REASON: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable...
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Today, FDA published a guidance paper for the use of augmented reality (AR) & virtual reality in medical devices. The information from that paper is provide below. Medical Extended Reality (XR), which includes Augmented Reality (AR) and Virtual Reality (VR), has the potential to deliver new types of treatments and diagnostics, transforming how and where...
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I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...
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Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 3/1/2024 Class II PRODUCT VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Recall Number: Z-1224-2024 REASON: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause...
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Oriented for Central European Time! Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: March 7 & 28, 2024 HOURS: TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920 per person Special discounts available...
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AAMI FDA neXus
SoftwareCPR® partner Mike Russell is attending the AAMI/FDA neXus medical device standards conference this week in Washington D.C., and chairing a panel. This year’s conference has added a third standards success track: application. Accordingly, Mike is chairing a panel session today on “Reducing Submission Rejections and Recalls with Software Standards.” In addition to his experience...
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Company: PTW-FREIBURG Date of Enforcement Report: 2/22/2024 Class II PRODUCT Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. Recall Number: Z-1181-2024 REASON: Software: If the user excludes voxels from the Gamma calculation that are below a dose...
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One of the cornerstones of a quality management system is the integrity of the quality system records. It should go without saying how critical it is for these records to be truthful, accurate, and genuine. Fraudulent data can lead to an unsafe medical device, or a medical device that does not fully achieve its intended...
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Company: Baxter Healthcare Co. Date of Enforcement Report: 02/16/2024 Class I PRODUCT ExactaMix Pro 1200 and the Pro 240 with software 2.0.8 and 2.1.8 Recall Number: Z-1002-2024 REASON: Baxter Healthcare is recalling the ExactaMix Pro 1200 and the Pro 2400 because of a software error that can cause more ingredients than needed to be added...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 2/16/2024 Class I PRODUCT Baxter Exactamix Pro 1200, REF EXM12DY Recall Number: Z-1001-2024 REASON: An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery...
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Company: Smiths Medical ASD, Inc. Date of Enforcement Report: 2/14/2024 Class I PRODUCT Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. Recall Number: Z-2107-2012 REASON: Smiths...
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Company: PHILIPS MEDICAL SYSTEMS Date of Enforcement Report: 2/8/2024 Class II PRODUCT Spectral CT on Rails: Software Version 5.1.0.X, model 728334 Recall Number: Z-1054-2024 REASON: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS VOLUME OF PRODUCT IN COMMERCE: US:...
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Shepherdly: A bug prediction & code resilience coverage tool In the context of software development, Resilience Coverage measures the overall protection a pull request has against bugs that can impact large portions of your user base and/or expose observability gaps. When coupled with a Software Quality Risk Score driven by a predictive model, engineers can...
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Company: Thoratec Corp. Date of Enforcement Report: 2/2/2024 Class I PRODUCT 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients....
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 2/1/2014 Class I PRODUCT Smith’s Medical Medfusion Model 3500 Syringe pump Recall Number: Z-0863-2024 REASON: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4....
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Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 1/30/2024 Class II PRODUCT Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Recall Number: Z-0860-2024 REASON: Loss of connectivity between the FlexArm and the Table due to a software issue. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VOLUME...
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Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...
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SoftwareCPR Training
62304 Public Training Course Course Dates:  June 5-7, 2024 CANCELLED COST: 3 Full Days for $2,900.00 (50% refundable through January 31, 2024. Fully transferable at any time.) Limited number of Early Bird discount coupons (worth $895)  available on a first come-first serve basis.  Use coupon code: (thats three-zero-letter p-letter e-letter r) Early bird discount available...
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Deymond Diagnostics s.r.o. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: The “inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for,...
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When to Ask Questions
Solving Problems Another great “soft skill” I learned from a mentor early in my career was knowing when to ask questions. You know, how long should I dig, research and investigate, before seeking the help of others? Some may gravitate toward spending too much time trying to find answers or solutions when it would have...
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iRythm Technologies, Inc. was issued a warning letter from the FDA. SoftwareCPR comments: This Warning Letter demonstrates the need for: Quality systems to stay compliant (CAPA and complaints!) Regulatory oversight to engineering and marketing activities Really communicating product behavior in the IFU!!” Excerpts from a warning letter of interest to software professionals: “As stated in...
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Company: Philips Healthcare (Suzhou) Co., Ltd. Date of Enforcement Report: 1/5/2024 Class II PRODUCT Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Recall Number: Z-0640-2024 REASON: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan....
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Company: Boston Scientific Corporation Date of Enforcement Report: 1/5/2024 Class II PRODUCT Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus....
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Company: Covidien Date of Enforcement Report: 1/3/2023 Class II PRODUCT Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD Recall Number: Z-0631-2024 REASON: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable. RECALLING FIRM/MANUFACTURER: Covidien VOLUME OF PRODUCT IN COMMERCE:...
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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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