Read on for some helpful questions to ask (essentially a “How-To” Guide for GUDID) when following GUDID, based on the recent FDA guidance document, “Global Unique Device Identification Database (GUDID).” “How-To” Guide for GUDID What does the UDI rule require labelers to do? Include a unique device identifier (UDI) on device labels and packages...Read More
Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. In this post we discuss FTA and FMEA/FMECA methods. How do these methods align with specific...Read More
Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. Common questions: What activities should the development team perform? How do we capture the software analysis?...Read More
Started a series on software risk management on X in 2024 and plan to finish it out here in the first part of 2025. Look for more to come in this series! Follow this link for more detail in the X post … #iso14971 #riskmanagement must start VERY early in the #productrealization process. Even as...Read More
Company: Elekta, Inc. Date of Enforcement Report: 2/11/2025 Class II PRODUCT MOSAIQ Oncology Information System Recall Number: Z-1162-2025 REASON: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. RECALLING FIRM/MANUFACTURER: Elekta, Inc. VOLUME OF PRODUCT IN COMMERCE: 64 units DISTRIBUTION: US: PA, AL, FL,...Read More
Company: Beckman Coulter, Inc. Date of Enforcement Report: 2/06/2025 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument Recall Number: Z-1115-2025 REASON: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. RECALLING FIRM/MANUFACTURER: Beckman Coulter,...Read More
Company: Medicrea International. Date of Enforcement Report: 2/06/2025 Class II PRODUCT UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display,...Read More
Company: Medicrea International Date of Enforcement Report: 2/06/2025 Class II PRODUCT UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display,...Read More
Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 2/04/2025 Class I PRODUCT Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration. Recall Number: Z-1019-2025 REASON: Large Volume Pump Software, version 5.9.2 and earlier...Read More
Improving medical device software development isn’t just about adding or modifying. The simplest approach is to NOT do things that don’t need doing. This is a key theme we cover in our training and consulting. “Faster, better, cheaper” is easier to attain when you do less and reduce complexity. The same applies to safety and...Read More
WARNING LETTER Robbins Instruments, LLC was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 687984 2003 Edwards Street Houston, TX 77007 United States Dates: March 27 through May 31, 2024 Inspection Issue(s): The report states that, “FDA has learned that your firm is marketing the Dermo-Jet Needleless...Read More
Company: Ortho-Clinical Diagnostics, INC. Date of Enforcement Report: 1/21/2025 Class II PRODUCT Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component Recall...Read More
Developing safe and effective medical device software is not easy. Doing that efficiently AND meeting regulatory compliance requirements is even harder. Many companies are implementing agile or lean software development methods to improve results. But can those methods also be compliant at the same time? Yes! There is a caveat, however … agile approaches “out...Read More
The Agile & Compliant February courses have early registration discount deadlines are coming up soon: Americas: 14 January 2025 EU et al: 21 January 2025 Pacific: 28 January 2025 Full details and registration form at https://www.softwarecpr.com/2024/12/1st-quarter-2025-agile-compliant-courses-scheduled/Read More
Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 1/07/2025 Class II PRODUCT Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. Recall Number: Z-0810-2025 REASON: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 12/27/2024 Class II PRODUCT SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B Recall Number: Z-0771-2025 REASON: Software issues were identified in application version 2.x. RECALLING FIRM/MANUFACTURER: Medtronic Neuromodulation...Read More
Company: Braemar Manufacturing, LLC Date of Enforcement Report: 12/23/2024 Class I PRODUCT Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. Recall Number: Z-0708-2025 REASON: Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an...Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/20/2024 Class II PRODUCT epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood...Read More
Company: Nova Biomedical Corporation Date of Enforcement Report: 12/20/2024 Class I PRODUCT StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing Recall Number: Z-0681-2025 REASON: A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare...Read More
Company: Mint Medical GmbH Date of Enforcement Report: 12/19/2024 Class: II PRODUCT: mint Lesion, Software Versions: 3.9.0 through 3.9.5 Recall Number: Z-0709-2025 REASON: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. RECALLING FIRM/MANUFACTURER: Mint Medical GmbH VOLUME OF PRODUCT IN COMMERCE: 65 units...Read More
Company: Hermes Medical Solutions AB Date of Enforcement Report: 12/12/2024 Class II PRODUCT Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0 Recall Number: Z-0678-2025 REASON: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. RECALLING FIRM/MANUFACTURER: Hermes...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class II PRODUCT BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 Recall Number: Z-0671-2025 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2)...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class II PRODUCT BD Pyxis MedStation ES, REF: 323 Recall Number: Z-0670-2025 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different...Read More
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 with group exercises, quizzes, examples, Q&A.
Instructor: Brian Pate
Next public offering: June 24-26, 2025 (Virtual, Live)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
Lead Instructor: Mike Russell
Next public offerings:
TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled
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)
