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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...
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Solving Problems Another great “soft skill” I learned from a mentor early in my career was knowing when to ask questions. You know, how long should I dig, research and investigate, before seeking the help of others? Some may gravitate toward spending too much time trying to find answers or solutions when it would have...
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Company: Acclarent, Inc. Date of Enforcement Report: 10/20/2023 Class II PRODUCT TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Recall Number: Z-0127-2024 REASON: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended...
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Company: EITAN MEDICAL LTD Date of Enforcement Report: 10/19/2023 Class I PRODUCT Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) Recall Number: Z-0094-2024 REASON: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. RECALLING FIRM/MANUFACTURER: EITAN MEDICAL LTD VOLUME...
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Company: OLEA MEDICAL Date of Enforcement Report: 10/18/2023 Class II PRODUCT Functional MR V1.0 Recall Number: Z-0122-2024 REASON: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to...
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Company: Blue Belt Technologies, Inc Date of Enforcement Report: 10/05/2023 Class II PRODUCT Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 Recall Number: Z-0041-2024 REASON: CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees...
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Company: Philips North America Llc Date of Enforcement Report: 09/29/2023 Class II PRODUCT EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 Recall Number: Z-2654-2023 REASON: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. RECALLING...
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Company: Philips Healthcare Date of Enforcement Report: 09/29/2023 Class II PRODUCT Incisive CT, software version 5.0 Recall Number: Z-2520-2023 REASON: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 09/29/2023 Class II PRODUCT Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Recall Number: Z-2657-2023 REASON: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 09/28/2023 Class II PRODUCT BD Pyxis MedBank MedPass Software, REF: 139088-01 Recall Number: Z-2646-2023 REASON: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to...
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Company: Exocad GmbH Date of Enforcement Report:9/25/2023 Class II PRODUCT exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. Recall Number: Z-2633-2023 REASON: A software library filtering error has been discovered which occurs when...
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By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...
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What does the US FDA expect in a premarket submission for description of the software design?  In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance. For lower risk devices, the manufacturer is not required to...
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Company: Diversatek Healthcare Date of Enforcement Report: 09/07/2023 Class III PRODUCT ZVU Functional GI Software, REF: ZVU-3 Recall Number: Z-2521-2023 REASON: GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. RECALLING FIRM/MANUFACTURER: Diversatek Healthcare VOLUME OF PRODUCT IN COMMERCE: 20 DISTRIBUTION: Worldwide – US Nationwide distribution in the states...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 08/25/2023 Class II PRODUCT RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 Recall Number: Z-2464-2023 REASON:...
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Company: Stryker Corporation Date of Enforcement Report: 08/25/2023 Class II PRODUCT SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090. Recall Number: Z-2463-2023 REASON: Potential for current software to miscount when scanning in multiple...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 07/21/2023 Class II PRODUCT A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Recall Number: Z-2226-2023 REASON: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application...
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Company: Hamilton Medical, Inc. Date of Enforcement Report: 07/21/2023 Class I PRODUCT HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recall Number: Z-2139-2023 REASON: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop...
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Company: Digisonics, Inc Date of Enforcement Report: 07/20/2023 Class II PRODUCT Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software Recall Number: Z-2214-2023 REASON: Software issue RECALLING FIRM/MANUFACTURER: Digisonics, Inc VOLUME OF PRODUCT IN COMMERCE: 32 units DISTRIBUTION: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY,...
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Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 07/14/2023 Class II PRODUCT Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Recall Number: Z-2144-2023 REASON: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 07/13/2023 Class I PRODUCT SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Recall Number: Z-2103-2023 REASON: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported...
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Software risk analysis requires consideration of both the development process itself and the runtime environment.
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The recent FDA guidance, Content of Premarket Submissions for Device Software Functions (June 14, 2023), points out that software design is a prospective activity and should not be done in an ad-hoc or last-minute approach.
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Company: RaySearch America Inc Date of Enforcement Report: 07/03/2023 Class II PRODUCT Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Recall Number: Z-2039-2023 REASON: A software bug affecting results when...
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#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?
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Company: Philips North America Llc Date of Enforcement Report: 06/29/2023 Class II PRODUCT DigitalDiagnost C90, Model No. 712034 and 712035 Recall Number: Z-2042-2023 REASON: There is a software login in issue that may prevent the user from logging in. RECALLING FIRM/MANUFACTURER: Philips North America Llc VOLUME OF PRODUCT IN COMMERCE: 58 DISTRIBUTION: Distribution in US:...
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Company: Appliedvr Date of Enforcement Report: 06/29/2023 Class II PRODUCT RelieVR REF: RVX-2002, Rx Only Recall Number: Z-2044-2023 REASON: There is the potential for the program software to malfunction which will not allow it to move forward to the next session. RECALLING FIRM/MANUFACTURER: Appliedvr VOLUME OF PRODUCT IN COMMERCE: 1 unit DISTRIBUTION: US: NY OUS:...
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The US regulations for design controls have requirements for design and development planning.  In fact, a design and development plan is an indication that a manufacturer has “exited” research phase activities and entered the development phase, and thus, design controls should be in place.  The regulation, 21 CFR 820.30(b), specifically states: Design and development planning....
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Company: SenTec AG Date of Enforcement Report: 06/20/2023 Class II PRODUCT V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Recall Number: Z-1980-2023 REASON: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. RECALLING...
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Company: Illumina, Inc. Date of Enforcement Report: 06/16/2023 Class II PRODUCT NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Recall Number: Z-1976-2023 REASON: Cybersecurity vulnerability concerning the software used for sequencing instruments. RECALLING FIRM/MANUFACTURER: Illumina, Inc. VOLUME OF PRODUCT IN COMMERCE: 1067 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries...
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Company: Datascope Corp. Date of Enforcement Report: 06/14/2023 Class III PRODUCT Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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Our partner Windi Hary and I annotated a recent FDA Warning Letter.  There is much one can learn from Warning Letters and we highly encourage our clients to make review and analysis of warning letters a regular part of your quality program. Click here to download this teaching aid:  Warning Letter – iRhythm Technologies, Inc...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...
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Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Recall Number: Z-1630-2023 REASON: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other...
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The US FDA has a continuous challenge trying to ensure that regulations keep up with advancements in technology.  As with any new technology, manufacturers try and make the existing regulations applicable, while FDA assesses whether or not existing regulations are appropriate for the new technology.  This involves FDA collecting data to inform whether new and/or creative...
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Effectively Communicating to FDA – being able to appropriately articulate what your software function is intended to do or intended to provide is – the foundation – the corner stone – the linchpin to navigating the correct path, investing your resource wisely, and defending your decisions now and into the future.  Solid foundations lead to solid futures....
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I cannot agree more … “The more you can divide up the behavior of your app into components, the more effectively you can test that the behavior of your code meets the reference standards in all particulars as your project grows and changes. For a large project with many components, you’ll need to run a large number of tests to test...
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In September 2022, FDA Updated the Software Guidance Policy for Device Software Functions and Mobile Medical Applications.  Last revised in September 2019, the policy is intended to clarify FDA’s regulatory oversight on software functions, including those used on mobile platforms and general-purpose computing platforms as well as software in the function or control of a...
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On November 15, 2022, I had the pleasure to log in to a “live” FDA CDRH Industry Basics Seminar on Understanding Risk with Medical Devices.  You can view the workshop at this link: https://fda.yorkcast.com/webcast/Play/4aecf454d2d54039a1d5a6a3001d78c31d I did enjoy the materials presented and I do think the presenters Joseph and Tonya did a great job. I would recommend...
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FDA Updates Cybersecurity Playbook for Health Care Organizations The healthcare sector knows how to prepare for and respond to natural disasters. It is less prepared, however, to handle cybersecurity incidents, particularly those involving medical devices.  With healthcare-related cyber incidents growing in size and scope, preparedness before a cyber event takes place with a strong, well-exercised,...
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Just a few thoughts on metrics … specifically software metric.  A software metric defines a standard way of measuring some attribute of the software development process or an attribute of a software component. A software metric allows us to compare and evaluate one process or component with another, and plan to improve quality of a...
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A course dedicated to “SaMD Risk Management Training?” Yes and much more! More discussion on Risk Management Training between our General Manager, Brian Pate, and our Partner, Dr. Peter Rech, regarding our January 2023 public training course on the application of ISO 14971 and IEC 62304 to system risk analysis and software risk analysis.  Our...
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I recently spoke with Dr. Peter Rech about the 2019 update to ISO 14971 as he and I prepare for our upcoming public training course on January 9-11, 2023, in Tampa, Florida USA.  Registration information can be found at this post: 14971 Risk Management Training Course If you would like more information on applying IEC 62304...
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In September 2022, the FDA Software Precertification Pilot Ends, or has officially “completed” the Software Precertification (Pre-Cert) Pilot Program.  See: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program?utm_medium=email&utm_source=govdelivery The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of...
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What are non-device software functions according to the FDA?  The 21st century cures act excluded certain types of software.  The term device, as defined in section 201(h), shall not include a software function that is intended— (A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or...
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Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...
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This March 2022 Standards Navigator Report 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, our report keeps you...
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What is CAPA?   Corrective and Preventive Action (CAPA) is a fundamental quality process for medical device manufacturers including SaMD.  From the regulations it is really not that complicated.   21 CFR 820.100 reads: (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: (1)...
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When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun.  Often this is due to the nature of research itself – one is exploring a concept or design approach that may or may not pan out in the end.  The US...
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SoftwareCPR Training Courses:

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.

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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!

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Next public offering: February 12-15, 2024

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Medical Device Cybersecurity (Public or Private)

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.

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