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...Read More
62304 Public Training Course Course Dates: June 5-7, 2024 COST: 3 Full Days for $2,900.00 Limited number of Early Bird discount coupons available on a first come-first serve basis. To obtain the coupon code, email your request to: training@softwarecpr.com Register Now: https://softwarecpr.regfox.com/2023-softwarecpr-62304-public-training-course This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical...Read More
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...Read More
The Open Worldwide Application Security Project (OWASP) released a white paper titled OWASP Top 10 for LLM. The introduction states, The frenzy of interest of Large Language Models (LLMs) following of mass-market pre- trained chatbots in late 2022 has been remarkable. Businesses, eager to harness the potential of LLMs, are rapidly integrating them into their...Read More
Recalled Product Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to June 13, 2022 Devices Recalled in the U.S.: 300 Date Initiated by Firm: June 12, 2023 Device Use The Oxylog 3000 Plus Emergency and Transport Ventilator is...Read More
A former employee forges FDA clearance letters at a Philadelphia-area medical device manufacturer. Peter Stoll III pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce, in violation of 21 United States Code, Section 331(a) and 331(a)(2). ...Read More
Tampa, FL, July 13, 2023. Crisis Prevention and Recovery, LLC, dba SoftwareCPR® is pleased to announce that our partner, Dr. Peter Rech, has received the Certified Information Systems Security Professional (CISSP) prestigious certification. Peter has led the SoftwareCPR staff in cybersecurity related activities for our clients and is one of the premier regulatory experts with...Read More
In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management. Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.” The guidance covers the general quality risk management process but discusses the roles and responsibilities...Read More
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.Read More
#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?Read More
FDA released a draft guidance document for patient matched guides for orthopedic implants. The guidance provides recommendations to manufacturers regarding the design-and-production process for these types of devices. Patient matched guides, as the name implies, are unique to the patient and are created to assist pre-surgical planning. The clinician is better able to visualize proper...Read More
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....Read More
In March 2023, FDA released a draft guidance on Part 11 Application to Clinical Investigations. The specific introduction in the guidance stated: This document provides guidance to sponsors, clinical investigators, institutional review boards(IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations...Read More
FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions. This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...Read More
Tampa, FL, May 10, 2023. Crisis Prevention and Recovery, LLC, dba SoftwareCPR® announced today that Windi has joined SoftwareCPR® as a Partner. In her role, Windi will lead the expert regulatory and quality team, bringing a unique client-side perspective for both US, Canada, UK/EU, and Japan markets. Windi’s career path is one marked by a...Read More
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...Read More
The FDA completed its review of an Automated Ejection Fraction SaMD De Novo leading to a new Class II code, ‘QVD.’ The FDA notice follows including the special controls. FDA Notice Re: DEN220063 Trade/Device Name: Caption Interpretation Automated Ejection Fraction Software Regulation Number: 21 CFR 892.2055 Regulation Name: Radiological machine learning-based quantitative imaging software with...Read More
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...Read More
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...Read More
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
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: June 5-7, 2024 Boston, MA
Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.
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)
