Guiding clients to effective and efficient compliance and regulatory approvals

Do you have a question about FDA Digital Health Regulatory Policy?  FDA’s Center for Devices and Radiological Health has a resource to help. I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner. During my...
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Company: Abiomed, Inc. Date of Enforcement Report: 11/13/2019 Class II PRODUCT lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI Recall Number: Z-0345-2020 REASON This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 11/13/2019 Class II PRODUCT Prismaflex Control Unit, software versions below 7.21 Recall Number: Z-0276-2020 REASON Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 10/4/2019. Voluntary: ...
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Company: Zimmer Biomet Date of Enforcement Report: 11/7/2019 Class I PRODUCT The ROSA Brain device is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments may be attached to...
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Company: Medical Components, Inc dba MedComp Date of Enforcement Report: 11/6/2019 Class II PRODUCT C3 Wave App, v. 2.0.5 Recall Number: Z-0222-2020 REASON When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or...
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DATES:  February 4-6, 2020 COST: 3 Full Days for $2,595.00 (Registration closes 1/14/2020) Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! Volume Discount:  $450 off for multiple students from same company Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 This three-day course provides a clear understanding of the 62304 standard for medical device software, FDA...
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This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., CDER-led combination product) and the device portion has electronics and/or software that is planned to be used as a platform, that is,...
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A probe into a series of engine failures on Airbus’s smallest jet, the A220, is studying whether a software change set off unexpected vibrations that damaged fast-moving parts and forced three emergency landings. Investigators are focusing their attention on recent changes in engine software that may have caused parts that compress air inside the engine...
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FDA-NCATS Report
The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment to better understand unmet medical device needs for rare diseases – ultimately to raise public awareness of these unmet needs.  Let this motivate us all to explore, push limits, innovate, and invent.  Onward software...
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Registration for our 62304 and Emerging Standards software course February 4-6, 2020, in Sunnyvale, CA is in full swing!  Onward to higher software quality – keep pressing forward!
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Company: Abbott Laboratories, Inc Date of Enforcement Report: 10/16/2019 Class II PRODUCT Alinity S System, Part Number 06P16-01 Recall Number: Z-0111-2020 REASON Two software issues have been identified for the Alinity S System containing software version 2.0.0: Alinity’s Probe Wash: When Alinity’s CMV IgG Qualitative assay is run as the last assay on a sample,...
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One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...
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The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Denterprise International, Inc., 100 E. Granada Blvd. Ste. 219, Ormond Beach, Florida, from May 1, 2019 to May 6, 2019. During the inspection, an FDA investigator determined that your firm is a specifications developer, manufacturer of the...
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Company: WOM World of Medicine AG Date of Enforcement Report: 10/9/2019 Class II PRODUCT Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Recall Number: Z-2767-2019 REASON The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk....
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Company: ELITech Group B.V. Date of Enforcement Report: 10/9/2019 Class III PRODUCT Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 – Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been...
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Company: Elekta Inc Date of Enforcement Report: 10/2/2019 Class II PRODUCT Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and...
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/2/2019 Class II PRODUCT Proteus XR/a (SlOK : K993090) Recall Number: Z-2449-2019 REASON Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC on 8/9/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Vital Scientific N.V. Date of Enforcement Report: 10/2/2019 Class II PRODUCT V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of...
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Company: Roche Diabetes Care, Inc. Date of Enforcement Report: 10/2/2019 Class II PRODUCT Accu-Chek Connect Diabetes Management App Recall Number: Z-2753-2019 REASON Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. RECALLING FIRM/MANUFACTURER Roche Diabetes Care, Inc. on 5/3/2019. Voluntary:  Firm Initiated recall is...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 10/2/2019 Class II PRODUCT Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1;...
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URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware...
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August and September 2019 continued a busy trend of regulatory and compliance activity – there were 42 software related recalls!  We also announced our 2020 Public Training Course dates!  Onward to higher software quality – keep pressing forward!
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Brian Pate has created this job aid to assist with explaining the separation of design input from the design process.  The diagram illustrates the "flow down" process of high level, intended use functionality traces downward to more detailed requirements and specifications.  Where do we draw the line with design input?  What should be the focus...
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The U.S. Food and Drug Administration released a suite of “Digital Health” guidances. The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act. The first guidance announced is Clinical Decision Support Software, a revised...
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

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