Guiding clients to effective and efficient compliance and regulatory approvals

Andrea Fox of HealthcareNewsIT (https://www.healthcareitnews.com/) reported on November 27, 2024, that OCR HIPAA enforcement is relatively lite.  When OCR (Office of Civil Rights) had identified serious compliance issues including discovery of security flaws, followup was rare according to the HHS inspector general’s (OIG) audit program review. The OIG review reviewed records from January 2016 through...
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Company: Abbott Medical Date of Enforcement Report: 11/26/2024 Class: III PRODUCT Merlin@home Transmitter REF EX1100 The Merlin@home” (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net” Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device...
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Company: Zyno Medical LLC Date of Enforcement Report: 11/22/2024 Class: III PRODUCT Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional. Recall...
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Company: Philips Medical Systems Technologies Ltd. Date of Enforcement Report: 11/20/2024 Class: II PRODUCT Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites. Recall Number: Z-0497-2025...
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Oriented for Central European Time! Registration now open for our next “Being Agile and Yet Compliant” Training Course. COURSE DATES: Dec 3, 4, & 5, 2024 HOURS: 12:00 pm to 5:00 pm CET TRAINING LOCATION: Virtual – live online COST: 3 half days for $1,520 per person Registration Link:  https://softwarecpr.regfox.com/dec-2024-agile-compliant-training-course Our course is framed around IEC...
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Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Date of Enforcement Report: 11/07/2024 Class II PRODUCT SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography. Recall Number: Z-0316-2025 REASON: X-ray R/F system software with certain versions of the control board may...
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Company: Philips North America Llc. Date of Enforcement Report: 10/4/2024 Class II PRODUCT IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there...
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WARNING LETTER Rolence Ent. Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 695010 Rolence Ent. Inc. No. 18-3, Lane 231 Pu Chung Road Taoyuan District, Taoyuan City 32083 Taiwan Dates: July 8, 2024, through July 11, 2024 Inspection Issue(s): Report states, “This inspection revealed that...
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Company: Boston Scientific Corporation Date of Enforcement Report: 10/16/2024 Class II PRODUCT Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral...
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Company: Agfa Healthcare NV Date of Enforcement Report: 10/10/2024 Class II PRODUCT Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 10/10/2024 Class II PRODUCT StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Recall Number: Z-0050-2025 REASON: Due to two...
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(Tampa, FL, October 9, 2024) – Crisis Prevention and Recovery, LLC is taking proactive steps to minimize impact to our clients from the landfall of Hurricane Milton in Southwest Florida.  With our corporate office in Tampa, Florida, there is a possibility of short term loss of electrical power and/or internet in the next 24 to...
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Company: Zyno Medical LLC Date of Enforcement Report: 10/9/2024 Class II PRODUCT Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Recall Number: Z-0005-2025 REASON: There is a defect in the air-in-line software algorithm. RECALLING FIRM/MANUFACTURER: Zyno...
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Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/07/2024 Class II PRODUCT Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Recall Number: Z-0025-2025 REASON: When the DxI 9000 Access Immunoassay Analyzer with...
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Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/03/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...
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Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/3/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...
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Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...
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Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/24/2024 Class II PRODUCT ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. Recall Number: Z-3215-2024 REASON: If ultrasound systems with software, are changed from factory default to :...
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Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3135-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...
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Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3134-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...
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Company: Mazor Robotics Ltd Date of Enforcement Report: 9/16/2024 Class II PRODUCT Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Recall Number: Z-3156-2024 REASON: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw...
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Company: Philips Respironics, Inc. Date of Enforcement Report: 9/4/2024 Class I PRODUCT Trilogy Evo EV300 — Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA...
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Company: Medtronic Inc. Date of Enforcement Report: 9/13/2024 Class II PRODUCT 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description:...
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WARNING LETTER Micro-X Ltd. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 692084 Micro-X Ltd.. 6 MAB Eastern Promenade, Unit 14Tonsley SA 5042Australia Dates:  May 20, 2024, through May 23, 2024 Inspection Issue(s): The report states, “This inspection revealed that these devices are adulterated within the...
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SoftwareCPR Training Courses:

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

Register Now


 

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

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

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.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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