Brian Pate, Author at SoftwareCPR

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Brian Pate

Jun

Warning Letter Analysis

June 8, 2023Brian PateBlog, Prem

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...

Jun

Automated Ejection Fraction SaMD De Novo

June 8, 2023Brian PateNews

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...

Mar

Unit Testing

March 14, 2023Brian PateBlog

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...

Nov

Thoughts on Metrics

November 11, 2022Brian PateBlog

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...

Oct

SaMD Risk Management Training

October 24, 2022Brian PateBlog

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...

Oct

October – Cybersecurity Awareness Month

October 12, 2022Brian PateNews

Since October is Cybersecurity Awareness Month, the US FDA released a new video to provide ideas and approaches for Healthcare Professionals (HCP) discuss and explain to patients, the concepts and methods for cybersecurity with regard to interconnected medical devices. The video titled, “xx,” is designed to promote, and perhaps facilitate, communication between HCPs and patients....

Oct

Dr Rech on ISO 14971 Updates

October 10, 2022Brian PateBlog

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...

Sep

Hurricane Ian – Possible Disruptions

September 28, 2022Brian PateNews

(Tampa, FL, September 28, 2022) – Crisis Prevention and Recovery, LLC is taking proactive steps to minimize impact to our clients from the landfall of Hurricane Ian in Southwest Florida. With our corporate office in Tampa, Florida, it is likely that there could be loss of electrical power and/or internet in the next 24 to 72...

Jul

New Cybersecurity Standard

July 26, 2022Brian PateNews

Recently, a new cybersecurity standard, IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle, was released. As the name implies, this standard addresses the overall software development lifecycle (SDLC) with regard to cybersecurity activities. For medical device manufacturers, this is very...

Jul

Non-Medical Device Software

July 14, 2022Brian PateNews

FDA is requesting input on patient safety, including best practices to promote patient safety, education, and competency, associated with Non-Medical Device Software – software excluded from the medical device definition by the 21st Century Cures Act. Software professionals should take this opportunity to explain the risks associated with non-medical device software interacting with medical device...

Apr

2022 FDA Premarket Cybersecurity Guidance

April 20, 2022Brian PateNews

FDA has released a new draft of Premarket Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Per the scope, this 2022 FDA Premarket Cybersecurity Guidance “is applicable to devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). The guidance is not limited to devices...

Dec

Transition from Research

December 29, 2021Brian PateBlog, Prem

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...

Dec

Post Market Risk Management

December 3, 2021Brian PateNews

AAMI Post Market Risk Management Report

Nov

Code Review Basics

November 23, 2021Brian PateBlog, Prem

This post discusses some code review basics - concepts and inspection ideas that one might use when performing a code review. A code review is a technical verification activity. The purpose is most often to identify coding errors against the design intent - one is verifying that the code actually accomplishes what that author intended....

Nov

Manufacture of Blood Components

November 4, 2021Brian PateNews

Nothing software specific in this guidance, Manufacture-of-Blood-Components-Using-Pathogen-Reduction-Device-2021, but in the future one might envision that the validation and quality control could be automated by software. Purpose of the document is to provide guidance to establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of...

Aug

SOUP – Can’t Live Without It!

August 30, 2021Brian PateBlog

Software of Unknown Provenance SOUP. It is likely that you are familiar with the acronym, SOUP, in relation to medical device and Health IT software. The medical device software standard IEC 62304, defines SOUP as a “software item that is: already developed and generally available and that has not been developed for the purpose of being...

Aug

FDA AI/ML Workshop

August 28, 2021Brian PateNews

You may be interested in attending the FDA Virtual Public Workshop, “Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices,” planned for October 14, 2021. Info on attending: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-transparency-artificial-intelligencemachine-learning-enabled-medical-devices

Aug

62304/FDA Public Training Course – Virtual

August 17, 2021Brian PateNews

IEC 62304 and Emerging Standards for Medical Device and Health IT Software DATES: Oct 19-21, 2021 Clock time each day: 8:30 am – 4:30 pm US Pacific COST: 3 Full Days for $2,100.00 (Early Bird discount: $1595 thru September 1, 2021) Special FDA / Government rate: $500 (contact us at training@softwarecpr.com to qualify) Multi-student discounts available....

Jul

DNA Software Under Scrutiny

July 31, 2021Brian PateNews

Probabilistic Genotyping Used for Criminal Prosecution In a recent article published on The Markup, software that is used to match DNA in criminal prosecution has come under scrutiny. The software implements what is known as probabilistic genotyping, a method used when analyzing data that contains a mixture of DNA from multiple people. The software uses complex...

Jul

Software Validation of Cloud Based Tools

July 25, 2021Brian PateBlog, Prem

Most medical device manufacturers use many, many software programs, systems, or services to automate quality system This software is not to be confused with product software - that is, software that runs as part of a medical device. Medical device in this context could be custom hardware devices or Software as a Medical Device (SaMD)....

Jul

General Principles of Software Validation

July 25, 2021Brian PateBlog, News

One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.” This guidance document has been around for many years. The current version, 2.0, was released in 2002. To many in the industry, this guidance is simply referred to...

Jul

Retaining Training Data Sets

July 23, 2021Brian PateBlog, Prem

As the use of Artificial Intelligence (AI) and machine learning methods expand in medical devices and HealthIT software, an oft asked question is whether the data sets used for training should be retained as part of the design history file (DHF) or other long term storage mechanisms. SoftwareCPR partners Alan Kusinitz, Sherman Eagles, John Murray,...

May

Standards Navigator Benefits

May 2, 2021Brian PateNews

Having trouble keeping up with standards activity? You are not alone! The pace of new and emerging standards creates a challenge for even the most organized and well staffed software and quality assurance teams. Whether it is digital health, risk management, software process, usability, or the ever challenging cybersecurity, being aware and understanding upcoming changes...

May

Standards Navigator

May 1, 2021Brian PateNews

In addition to information on existing standards, the SoftwareCPR Standards Navigator subscription keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards. Draft standards are available on a limited basis to subscribers to provide input to SoftwareCPR for the purpose of developing a position or...

Apr

Challenges and benefits of the microservice architectural style

April 4, 2021Brian PateBlog

An excellent overview of the challenges and benefits of the Microservices architectural style of software application development. While many of the factors discussed by the author (Dr. André Fachat, published January 30, 2019), these same factors can affect the safety and efficacy of a medical devices using this style. The article consists of two parts:...

Mar

62304/FDA Public Training Course – Virtual – April 6-8, 2021

March 29, 2021Brian PateNews

IEC 62304 and Emerging Standards for Medical Device and Health IT Software DATES: April 6-8, 2021 Clock time each day: 8:30 am – 4:30 pm US EDT COST: 3 Full Days for $2,100.00 (Early Bird discount extended! $1795 thru April 3rd) Multi-student discounts available. Register at EventZilla: https://events.eventzilla.net/e/2021-softwarecpr–iec-62304-and-emerging-standards-and-fda-expectations-for-medical-device-and-health-it-software-2138790469 This 62304 Public Training Course provides a...

Mar

Mike Russell joins SoftwareCPR as a partner

March 5, 2021Brian PateNews

(March 1, 2021)— Mike Russell has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a Partner. He is not new to the firm and industry, having assisted on many engagements in the last decade as an Affiliated Expert. He was also on the TIR working group that created the AAMI TIR45- 2012 Technical...

Nov

ISO 14971 Updated in 2019 Release

November 23, 2020Brian PateBlog, Prem

This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. ISO 14971 was updated and released in 2019. We previously discussed the internal debate regarding ISO 14917 in this post ISO 14971 versus the EU Commission. There are several items to consider with the new update: Section 10.1 - “The manufacturer...

Nov

Celebrating Veterans Day!

November 11, 2020Brian PateBlog

At SoftwareCPR today, we honor our consultants that are also veterans who served in our US military! John Murray – US Navy Mike Russell – US Air Force Greg Sandoe – US Marine Corps Jordan Pate – US Army Paul Felten – US Army Thank you for your service!

Oct

Understanding OTS and SOUP

October 30, 2020Brian PateBlog

Understanding OTS and SOUP is very important in every lifecycle stages of medical device and HealthIT software development. In the late 1990’s, the US FDA first published guidance documentation on the use of Off-The-Shelf (OTS) software in medical devices (or sometimes referred to as “OTSS”). At that time, OTSS generally accounted for a very small...

Sep

SoftwareCPR 62366-1:2015, A1:2020 Checklist

September 22, 2020Brian PatePrem

This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment. This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version...

Sep

62304/FDA Public Training Course – Virtual – Sep 22-24, 2020

September 18, 2020Brian PateNews

62304 Public Training Course DATES: September 22-24, 2020 (Registration is open through September 21, 2020 as seats remain.) COST: 3 Full Days for $2,100.00 Company Discount: First two students at full price and then 10% off for any others (up to course size limit) This 62304 Public Training Course provides a clear understanding of the...

Aug

SoftwareCPR August 2020 Newsletter

August 22, 2020Brian PateNews

SoftwareCPR August 2020 Newsletter has been published. FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.

Aug

My Software Is a Medical Device (SaMD). Now What?

August 20, 2020Brian PateNews

My Software Is a Medical Device … if that’s you, check out this upcoming webinar. Our very own John Murray will participate in a webinar on August 25, 2020, and join a roundtable discussion with Bakul Patel, Director, Division of Digital Health at FDA. Shawnnah Monterrey, CEO @BeanStock Ventures will moderate the discussion. You can...

Jul

Amy Sellers joins SoftwareCPR

July 13, 2020Brian PateNews

(July 13, 2020) Amy Sellers, of Tampa, FL, USA, has joined SoftwareCPR as a Regulatory Associate. Amy recently received her J.D. from the University of Florida Levin College of Law. She has experience in regulatory pathway decisions, including analysis of intended use and product claims, as well as analysis of design changes against US regulations...

Jul

Software CAPA Can be Challenging

July 12, 2020Brian PateBlog, Prem

This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier. Just the name itself, corrective and preventive action, describes one of the...

Apr

Non-Binding Feedback FDA Inspections

April 21, 2020Brian PateNews

FDA released a new guidance document titled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments, Guidance for Industry and Food and Drug Administration Staff. This guidance was issued on April 22, 2020. The background on the guidance states, “Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are...

Apr

COVID-19 Public Health Emergency – Infusion Pumps

April 6, 2020Brian PateNews

U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID- 19) Public Health Emergency. FDA believes the policy set forth in this guidance may help address these urgent public health concerns by helping to expand the availability and remote capabilities...

Mar

FDA Public Workshop – Artificial Intelligence in Radiological Imaging

March 27, 2020Brian PateNews

On February 25-26, 2020 the U.S. Food and Drug Administration (FDA) held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments.

Mar

European Commission to delay MDR due to COVID-19

March 26, 2020Brian PateNews

Today (25 March 2020), the Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as a guiding principle.

Feb

Reclassification of Medical Image Analyzers

February 27, 2020Brian PateNocat

FDA has issued a final order to reclassify: medical image analyzers applied to mammography breast cancer ultrasound breast lesions radiograph lung nodules radiograph dental caries detection all which are post-amendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s...

Feb

Warning Letter – Software Validation Shortcomings

February 26, 2020Brian PateNews

December 26, 2019 Excerpts from warning letter of interest to software professionals: “The inspection also revealed that your … LED light therapy devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage,...

Feb

SoftwareCPR February 2020 Newsletter

February 6, 2020Brian PateNews

Kicking off the new year with regulatory and standards updates. New public courses in 2020!

Jan

Cybersecurity Vulnerabilities – GE Healthcare Clinical Information System

January 23, 2020Brian PateNews

FDA is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored. Per the FDA notice: “A security firm has identified several vulnerabilities in certain GE Healthcare Clinical Information Center workstations and Telemetry Servers,...

Jan

FDA GPSV Traceability Expectations

January 23, 2020Brian PateBlog, Prem

This "FDA GPSV Traceability Expectations" post is only available to Premium subscribers. See our Subscribe page for information on subscriptions. Going way back to the late 1990's, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness...

Jan

How do I know if I have a medical device?

January 16, 2020Brian PateNews

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!

Jan

62304/FDA Public Training Course – SF Area – Feb 4-6, 2020

January 16, 2020Brian PateNews

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,...

Jan

IEEE to create a model for safer automated vehicles

January 10, 2020Brian PateNews

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...

Dec

Challenges with Software Risk Analysis

December 19, 2019Brian PateBlog, Prem

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...

Oct

New CDER Guidance on Platform Software

October 29, 2019Brian PateNews

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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Risk Management (Public or Private)

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.

Instructor: Brian Pate, 2nd instructor (optional)

Next public offering: TBD

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