New to medical device software? Our partners Mike Russell and Ginny Kwan Gattinger will be presenting a Regulatory Affairs Professional Society (RAPS) webinar on Wednesday, May 17, 2023 at 1:00 pm EDT to discus the unique and amplified challenges with software development for SiMD and SaMD. They will discuss approaches for addressing the challenges and...Read More
Company: Hamilton Medical AG Date of Enforcement Report: 4/25/2023 Class II PRODUCT HAMILTON-C6, REF: 160021 Recall Number: Z-1429-2023 REASON: Software error causes, safety ventilation malfunction, in which ventilation continues in the “safety ventilation” mode with audible/visible alarm – patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode...Read More
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...Read More
Company: Outset Medical, Inc. Date of Enforcement Report: 4/07/2023 Class II PRODUCT Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. Recall Number: Z-1351-2023 REASON: An...Read More
Company: Shanghai United Imaging Healthcare Co., Ltd Date of Enforcement Report: 4/7/2023 Class II PRODUCT Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 Recall Number: Z-1353-2023 REASON: Due to a software issue where the process of patient scanning, the scatter correction may...Read More
FDA Draft Submission Guidance AI/ML For Use of AI/Machine Learning-Enabled Device Software Functions Almost every day there is another news story about something involving “artificial intelligence.” So it seems timely that the FDA has just released a draft guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...Read More
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....Read More
(Denis Pasero. Med-Tech News. 3-10-23) Microbatteries in implantable devices are allowing earlier detection along with closer and more regular observation of the patient. A major benefit would be the real-time monitoring of the patient in areas not previously possible due to size, comfort levels, and the complexity of surgery. Much work is still to be...Read More
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...Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 3/01/2023 Class II PRODUCT Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 Recall Number: Z-1192-2023 REASON: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new...Read More
Company: Stryker Corporation Date of Enforcement Report: 2/27/2023 Class II PRODUCT Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss. RECALL NUMBER: Z-1184-2023 REASON: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output...Read More
(Jim Lynch. Science Daily. University of Michigan. 01-02-2023) New 3D imaging capturing sound waves by X-rays provides the ability to map radiation doses. Doctors are now equipped with real-time data to guide treatments. Prior to this break through, medical professionals were left in the dark as to how much radiation was hitting their target area....Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 01/06/2023 Class II PRODUCT Devices Recall Number: Z-0911-2023 REASON Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation VOLUME OF PRODUCT IN COMMERCE 440 units DISTRIBUTION Worldwide distributionRead More
(Ann R. Thryft. 11-16-22. Mddionline.com) A team made up of Sensoria Health, Foot Defender, and former Nike shoe designers came together to create a cloud-based patient monitoring boot for Diabetes patients. On the extreme, but very realistic side, this technology could help save patients from requiring an amputation if used correctly after ulcer surgery. The...Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 12/31/2022 Class II PRODUCT Programmable Diagnostic Computer Recall Number: Z-0775-2023 REASON The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) “PASSWORD STORE CORRUPTED” error message during system boot;...Read More
(Med-TechNews, December 12, 2022). Sir Nicholas Wright and Digistain in the UK has created a new tool to aid the early detection of breast cancer. Based on clinical trials, this new development is helping those eligible successfully avoid chemotherapy through earlier and more personalized test results. This allows patients more time to make decisions, less...Read More
Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report:12/20/202 Class II PRODUCT 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126...Read More
RightEye, LLC was issued a Warning Letter from the FDA due to “the RightEye Vision System was cleared under K181771 with the following indications: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.” However, your firm’s promotion of the device provides evidence that the device is intended to...Read More
(November 8, 2022. Nick Paul Taylor. MedTech Dive) H2o Therapeutics is the company behind the app, Parky, which promises to track Parkinson’s symptoms using an Apple watch. Patients are able to take advantage of Apple’s pre-existing movement disorder API features in their wearables. This can provide valuable and reliable insight to clinicians between visits through...Read More
Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 22, 2022) “We are pleased to announce that our Partner and General Manager, Brian Pate, has been selected for membership on the UL 1998 Standards Technical Panel for Software (STP), with oversight of UL 1998 standard, Software in Programmable Components. Brian will provide stakeholder input to...Read More
Company: Abbott Molecular, Inc. Date of Enforcement Report: 11/18/2022 Class II PRODUCT Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use Recall Number: Z-0268-2023 REASON Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when...Read More
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...Read More
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...Read More
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: December 12-15, 2022 (16 hours of training) HOURS: 11 am until 3 pm EDT each day TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920...Read More
Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 15, 2022) “We are pleased to announce that our partner, Dr Peter Rech, has been reappointed to serve the next 3 years as convener for IEC technical committee 62/SC 62D/MT23 Infusion Pumps. In this role, Dr Rech will be responsible for organizing and administering...Read More
Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective training course is now open for scheduling!
Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
System level hazards analysis – mapping to software, cybersecurity, and usability
Why FMEA is incomplete for medical device risk management.
How to perform software hazards analysis.
And more!
3-days onsite with group exercises, quizzes, examples, Q&A.
Instructors: Dr. Peter Rech, Brian Pate
Next public offering: 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 with group exercises, quizzes, examples, Q&A.
Instructors: Mike Russell, Ron Baerg
Next public offering: 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
IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private)
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.
