IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software Course Dates/Location: October 13-15, 2026 / Boise, ID COST: 3 Full Days for $2,400.00 (Fully transferable at any time.) Super Early Bird Pricing! First 10 registrations only $995 This course focuses on ensuring the participants are aware of the relevant standards and US...Read More
The electronic Submission Template And Resource (eSTAR) is a great aid for medical device submissions to the U.S. Food and Drug Administration (FDA). The eSTAR is “an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission” (https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program). However, the form can lull submitters into unduly delayed cybersecurity work....Read More
Company: Medtronic MiniMed, Inc. Date of Enforcement Report: 7/8/2026 Class: II PRODUCT: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 Recall Number: Z-2698-2026 REASON: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump...Read More
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
Company: IPG Medical Corporation Date of Enforcement Report: 6/24/2026 Class: II PRODUCT: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. Recall Number: Z-2554-2026 REASON: Software anomaly that causes a false display of error code 5018. RECALLING FIRM/MANUFACTURER: IPG Medical Corporation VOLUME: 198 units DISTRIBUTION: US Nationwide distribution in the state of MA.Read More
The EU Artificial Intelligence Act (AIA) introduces four definitions related to data. Three of the definitions are typical for what one would expect for segregating data: Training Data: data used for training an AI system through fitting its learnable parameters [Article 3 (29) AIA] Validation Data: data used for providing an evaluation of the trained...Read More
The EU AIA – Recital 67 states, “High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the training of models are used, with a view to ensure that the high-risk AI system performs as intended and safely...Read More
The EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is the first comprehensive legal framework for regulating artificial intelligence (AI). Since becoming law on August 1, 2024, the AIA aims to ensure AI is safe, respects fundamental rights, and promotes trustworthy innovation across the EU. [digital-strategy.ec.europa.eu] Core Approach The AIA takes a risk-based approach and classifies...Read More
MDR Annex XVI provides a list of products that are a specific category of items regulated under the EU Medical Device Regulation (MDR) 2017/745 even though they do not have an intended medical purpose. These are products are like medical devices in terms of functioning, risk profile, and application but are used for non-medical applications,...Read More
Below is a an updated post from 2020. that applies to AI implementation issues today. The original post was about how companies were converting to agile processes and the issues that were created. We see some of the same things happening with AI. As an experiment, I changed instances of the word “agile” in the...Read More
An article on ZDNET by Steven Vaughan-Nichols, purports that AI may be useful for finding bugs in software, but AI also may be inserting bugs into new software at a rate exceeding human programmers. Key takeaways listed by the article: AI is proving better than expected at finding old, obscure bugs. Unfortunately, AI is also...Read More
Company: Abiomed, Inc. Date of Enforcement Report: 6/12/2026 Class: I PRODUCT: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU....Read More
Nice overview article of Grad CAM (Gradient-weighted Class Activation Map) which can be used to generate “heatmaps” highlighting the relevant regions of an image that contributed to the model design. This can be useful in documenting the “explainability” portion of the model documentation that one will likely need for a regulatory submission. Read More
Company: GE Medical Systems China Co., Ltd. Date of Enforcement Report: 6/3/2026 Class: II PRODUCT: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph Recall Number: Z-2306-2026 REASON: Software in development inadvertently made available for customer use. Use of this software version can result in clinical information...Read More
An FDA warning letter to a pharmaceutical manufacturer cites non-compliant use of AI use in manufacturer quality systems. It is also a warning about using AI in medical device manufacturing outside the typical algorithm and machine learning applications. The FDA sent a warning letter to Purolea Cosmetics Lab on April 2, 2026. The part about...Read More
Cybersecurity is a hot topic. For medical device manufacturers, it is also a required topic by regulation (e.g., in the U.S., section 524B of the FD&C act). However, that doesn’t mean that cybersecurity is “new.” There are lots of existing resources available to give you a jump-start in developing secure software. Here is one approach...Read More
Company: Dexcom, Inc. Date of Enforcement Report: 5/11/2026 Class: II PRODUCT: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App – The watchOS app is installed along with the iOS phone app and...Read More
Company: Technological Medical Advancements LLC Date of Enforcement Report: 5/11/2026 Class: II PRODUCT Diowave Laser System, REF: Diowave 250W Recall Number: Z-2162-2026 REASON: Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local...Read More
From the May 2026 SoftwareCPR newsletter – an edited excerpt about cyberattacks: Last month, we explained that cybersecurity monitoring is not optional extra work. It is a basic duty across the full life of a medical device. AI can help with monitoring effectively and efficiently. That duty is becoming even more important as AI becomes...Read More
After many years of navigating the difficult task of properly validating quality system and production software tools, FDA released the “Computer Software Assurance for Production and Quality Management System Software Guidance for Industry and Food and Drug Administration Staff” on February 3, 2026. While this release may have not been noticed by many, it is...Read More
Company: Beta Bionics, Inc. Date of Enforcement Report: 4/29/2026 Class: II PRODUCT: iLet Bionic Pancreas, REF: BB1001 Recall Number: Z-1996-2026 REASON: insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided,...Read More
Company: Boston Scientific Corporation Date of Enforcement Report: 4/24/2026 Class: I PRODUCT: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker,...Read More
Company: Gentuity, LLC Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; Recall Number: Z-1823-2026 REASON: The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to...Read More
Company: Philips Medical Systems Date of Enforcement Report: 4/16/2026 Class: II PRODUCT: Philips Spectral CT on Rails. Model Number: 728334 Recall Number: Z-1825-2026 REASON: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2....Read More
