We are pleased to announce our SoftwareCPR® Partner, Dr. Peter Rech, will lead the international working group meeting of IEC TC62/SC62D/MT23 Infusion Pumps as its Convenor. The meeting will be hosted by AAMI at the AAMI headquarters from April 22nd to 25th, 2024, in Arlington, VA. The meeting will be dedicated to the maintenance of...Read More
The FDA announced today that a Federal District Court has entered a Consent Decree Against Philips Respironics following recall of certain sleep therapy machines. The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP)...Read More
The DEFENSE IN DEPTH approach is to defend the system against any particular ATTACK using several independent methods. Often these might be referred to as “layers of protection.” Some have described it as the “swiss cheese slices” approach – there may be holes in each layer, but when stacked together they form a protective barrier....Read More
The U.S. Food and Drug Administration, Center for Devices and Radiological Health announced today that they had qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems (UCSF LAD MDDT), through the Medical Device Development Tools (MDDT) program. The University of California San Francisco (UCSF) Lethal...Read More
Company: Life Technologies Corporation Date of Enforcement Report: 3/29/2024 Class II PRODUCT Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx...Read More
Guidance Update: FDA revises Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The FDA released a revised draft of the Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program on 15 March, 2024. When finalized, this guidance will supersede both the current version of...Read More
Use of master files can be a convenient and strategic method for SaMD manufacturers or software suppliers to provide information necessary for a US regulatory submission without disclosing confidential and/or proprietary trade secrets to business partners. For example, a software supplier of a cloud library providing medical device functionality could submit a master file to...Read More
Company: Landauer Date of Enforcement Report: 3/21/2024 Class II PRODUCT microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059 Recall Number: Z-1349-2024 REASON: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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...Read More
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:...Read More
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...Read More
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....Read More
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....Read More
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...Read More
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...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 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.
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)
