SoftwareCPR is planning a series of training courses in Kuala Lumpur, Malaysia (for Malaysian citizens). Our instructors understand regulatory agency expectations, including US FDA and EU,  and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA and international standards terminologies. Our instructors have been in...Read More

Our ISO 13485 Internal Audit Training Course focuses on both the requirements of ISO 13485:2016 and the audit process and methods (ISO 19011) to ensure the manufacturer or supplier is compliant with the requirements of the standard. Our approach is to educate on the intent and purpose of the standard so that the participants are able...Read More

Company: Abbott Laboratories Date of Enforcement Report: 11/12/2025 Class: II PRODUCT: Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No Recall Number: Z-0489-2026 REASON: Software issue for hq analyzer results in...Read More

We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be...Read More

The international standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, provides the framework of the set of interrelated processes that work to ensure product quality.  This international standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be...Read More

Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 11/5/2025 Class: I PRODUCT: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient...Read More

Company: Dexcom, Inc. Date of Enforcement Report: 10/30/2025 Class: I PRODUCT: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/30/2025 Class: II PRODUCT: CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. Recall Number: Z-0412-2026 REASON: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device...Read More

Company: Vantive US Healthcare LLC Date of Enforcement Report: 10/29/2025 Class: II PRODUCT Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) Recall Number: Z-0409-2026 REASON: Vantive has identified a software defect within the Sharesource Claria software, which may...Read More

Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 10/23/2025 Class: II PRODUCT t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 10/10/2025 Class: I PRODUCT ACCOLADE SR SL (Model L300) Recall Number: Z-0079-2026 REASON: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes...Read More

Company: Bard Peripheral Vascular Inc Date of Enforcement Report: 9/26/2025 Class: II PRODUCT Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment...Read More

(Sep 13, 2025) FDA announces their 2025 Digital Health Advisory Committee Meeting On November 6, 2025, the FDA Digital Health Advisory Committee will discuss and make recommendations on the topic of generative artificial intelligence-enabled digital mental health medical devices. The Committee will discuss the benefits, risks to health, and risk mitigations that might be considered...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 9/16/2025 Class: II PRODUCT Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0...Read More

Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 9/9/2025 Class: II PRODUCT IntelliSpace Cardiovascular, Software 8.0.0.4. Recall Number: Z-2543-2025 REASON: Software issue that results in the display of outdated information. RECALLING FIRM/MANUFACTURER: Philips Medical Systems Nederland B.V. QUANTITY: 4 units DISTRIBUTION: US Nationwide distribution in the states of GA, NC & TX.Read More

Company: Dexcom, Inc Date of Enforcement Report: 9/4/2025 Class: I PRODUCT Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System Recall Number: Z-2446-2025 REASON: The...Read More

Company: mo-Vis BVBA Date of Enforcement Report: 9/2/2025 Class: I PRODUCT Micro Joystick R-net. Electrical wheelchair component. Recall Number: Z-2454-2025 REASON: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick...Read More

Company: Reflexion Medical, Inc. Date of Enforcement Report: 9/2/2025 Class: II PRODUCT RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is...Read More

Company: Medtronic MiniMed, Inc Date of Enforcement Report: 9/2/2025 Class: II PRODUCT InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Recall Number: Z-2496-2025 REASON: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/29/2025 Class: I PRODUCT Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Recall Number: Z-2332-2025 REASON: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 8/28/2025 Class: II PRODUCT BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis” MedStation” 4000 Main / 10885403512629 / 303 BD Pyxis” MedStation” ES Tower / 10885403512674 / 352 BD Pyxis” Anesthesia Station ES / 10885403477836 / 327 BD Pyxis” MedStation” ES (Main) /...Read More

Building high quality medical device software demands that we utilize many techniques to flush out latent bugs. Love this article about one technique that can be extremely helpful.Read More

Test groups beware, Google is changing their approach to loading Android applications on mobile devices as they will block sideloading of unverified Android apps. This will most likely impact 3rd party QA and software verification groups that utilize the side loading mechanism particularly during early testing phases.Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/5/2025 Class: II PRODUCT UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 Recall Number: Z-2266-2025 REASON: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/1/2025 Class: II PRODUCT Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Recall Number: Z-2239-2025 REASON: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the “Stopping Power Ratio” (SPR) , RECALLING FIRM/MANUFACTURER: Philips Medical Systems (Cleveland)...Read More