Guiding clients to effective and efficient compliance and regulatory approvals

How do I know if my device or my software is a medical device? Watch this helpful video and learn about the 513(g) process as well.  SoftwareCPR can help you plan your regulatory strategy and handle your regulatory submissions.  We would be delighted to help!
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62304 Public Training Course DATES:  February 4-6, 2020 (REGISTRATION extended through January 18, 2020) COST: 3 Full Days for $2,595.00 (Registration extended through 1/18/2020) Volume Discount:  $450 off for 4 or more students from same company Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software,...
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The Institute of Electrical and Electronics Engineers (IEEE) has approved a proposal to develop a standard for safety considerations in automated vehicle (AV) decision-making.  Purportedly, the “forthcoming IEEE standard will provide a useful tool to answer the question of what it means for an AV to drive safely,” according to the lead convener.  With technology...
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FDA Quality System (QS) Software Validation Public Training Course DATES:  June 2-4, 2020 COST: 3 Full Days for $2,595.00 (Registration closes 5/2/2020) Volume Discount:  $450 off for 4 or more students from same company Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-quality-system-software-validation-training-course–boston-ma-2138751888 This course covers software validation expectations for the whole range of Quality System Software (QSS) including computer systems validation,...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 1/1/2020 Class II PRODUCT RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 – Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment...
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Company: GE Healthcare, LLC Date of Enforcement Report: 1/1/2020 Class II PRODUCT ApexPro Telemetry System – Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system...
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Company: LivaNova USA Inc Date of Enforcement Report: 1/1/2020 Class I PRODUCT VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy Recall Number: Z-0561-2020 REASON Certain Model 1000 generators (SN = 100,000) have experienced unexpected device resets, which resulted in disablement of therapy. Fourteen (14) complaints have been reported....
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report 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...
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Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 12/25/2019 Class II PRODUCT VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of...
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Company: GE Healthcare, LLC Date of Enforcement Report: 12/25/2019 Class II PRODUCT Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571 Recall Number: Z-0114-2020 REASON Certain Aespire and Aestiva Anesthesia Systems were...
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The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced it has recalled GE’s ApexPro telemetry server after multiple reported events of monitoring equipment not providing visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring. The potential safety issues are: Patients can experience ECG arrhythmias before and after a “no telem” condition and...
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ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...
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Teaching 62304 Course
I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between...
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Thus far, regulatory guidance for medical device cybersecurity has been focused on the approval or compliance of the device itself and has not been very specific about what cybersecurity assurance information is provided to the health care customers that host the devices within their IT infrastructure.  Medical device labeling has been sparse related to cybersecurity...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 12/16/2019 Class I PRODUCT Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs. Recall Number: Z-0610-2020 REASON There is an anomaly in...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/20/2019 Class II PRODUCT Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and...
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Company: Draegar Medical Systems, Inc. Date of Enforcement Report: 11/20/2019 Class II PRODUCT Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 Recall Number: Z-0372-2020 REASON The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. RECALLING FIRM/MANUFACTURER Draegar...
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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: Medtronic Inc. Date of Enforcement Report: 11/13/2019 Class I PRODUCT Minimed Model 500 Remote Control for use with the MiniMed 508 Insulin Pump, model number MMT-500RU. Recall Number: Z-0177-2020 REASON There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. RECALLING FIRM/MANUFACTURER Medtronic Inc. on...
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Company: Insulet Corporation Date of Enforcement Report: 11/13/2019 Class II PRODUCT Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 Recall Number: Z-0347-2020 REASON There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last...
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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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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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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
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

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