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
IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software Course Dates: June 24-26, 2025 in Boston, MA COST: 3 Full Days for $2,900.00 (Fully transferable at any time.) Limited number of Early Bird discounts: Pay $1950 by January 31, 2025 (Fully refundable if course is not held) Early bird discount available through...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
Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class: II PRODUCT BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 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...Read More
Company: Fresenius Kabi USA Date of Enforcement Report: 12/05/2024 PRODUCT The Ivenix LVP is a large volume infusion pump designed to deliver fluids and medications from one of two inlet source containers to the patient through a single outlet. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient. UDI...Read More
Andrea Fox of HealthcareNewsIT (https://www.healthcareitnews.com/) reported on November 27, 2024, that OCR HIPAA enforcement is relatively lite. When OCR (Office of Civil Rights) had identified serious compliance issues including discovery of security flaws, followup was rare according to the HHS inspector general’s (OIG) audit program review. The OIG review reviewed records from January 2016 through...Read More
Company: Abbott Medical Date of Enforcement Report: 11/26/2024 Class: III PRODUCT Merlin@home Transmitter REF EX1100 The Merlin@home” (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net” Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device...Read More
Company: Zyno Medical LLC Date of Enforcement Report: 11/22/2024 Class: III PRODUCT Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional. Recall...Read More
WARNING LETTER Becton, Dickinson, and Company/CareFusion was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 691601 Becton, Dickinson, and Company/CareFusion 303, Inc. 1 Becton Drive Franklin Lakes, NJ 07417United States Dates: May 6, 2024 through May 22, 2024 Inspection Issue(s): Report states, “your firm manufactures Pyxis Medication...Read More
Company: Philips Medical Systems Technologies Ltd. Date of Enforcement Report: 11/20/2024 Class: II PRODUCT Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites. Recall Number: Z-0497-2025...Read More
Oriented for Central European Time! Registration now open for our next “Being Agile and Yet Compliant” Training Course. COURSE DATES: Dec 3, 4, & 5, 2024 HOURS: 12:00 pm to 5:00 pm CET TRAINING LOCATION: Virtual – live online COST: 3 half days for $1,520 per person Registration Link: COMPLETED Our course is framed around...Read More
Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Date of Enforcement Report: 11/07/2024 Class II PRODUCT SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography. Recall Number: Z-0316-2025 REASON: X-ray R/F system software with certain versions of the control board may...Read More
Company: Philips North America Llc. Date of Enforcement Report: 10/4/2024 Class II PRODUCT IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there...Read More
WARNING LETTER Rolence Ent. Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 695010 Rolence Ent. Inc. No. 18-3, Lane 231 Pu Chung Road Taoyuan District, Taoyuan City 32083 Taiwan Dates: July 8, 2024, through July 11, 2024 Inspection Issue(s): Report states, “This inspection revealed that...Read More
Company: Boston Scientific Corporation Date of Enforcement Report: 10/16/2024 Class II PRODUCT Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral...Read More
Company: Agfa Healthcare NV Date of Enforcement Report: 10/10/2024 Class II PRODUCT Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and...Read More
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:
Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled
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: June 24-26, 2025 (Boston, MA)
Special pre-registration discount through January 31, 2025
Private, in-house courses can be scheduled. Contact us.
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)
