Brian Pate, Author at SoftwareCPR

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Brian Pate

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,...

Oct

2018 FDA-NCATS Report on Unmet Medical Device Needs

October 24, 2019Brian PateBlog

The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment to better understand unmet medical device needs for rare diseases – ultimately to raise public awareness of these unmet needs. Let this motivate us all to explore, push limits, innovate, and invent. Onward software...

Oct

IPnet Cybersecurity Vulnerabilities – Urgent

October 1, 2019Brian PateNews

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware...

Sep

SoftwareCPR September 2019 Newsletter

September 30, 2019Brian PateNews

August and September 2019 continued a busy trend of regulatory and compliance activity – there were 42 software related recalls! We also announced our 2020 Public Training Course dates! Onward to higher software quality – keep pressing forward!

Sep

Challenges with Using C

September 16, 2019Brian PateNews

The 2015 Amendment 1 update to IEC 62304 added a new clause that requires identification of “categories of defects associated with the selected programming technology” and providing analysis and other evidence demonstrating “that these defects do not contribute to unacceptable risk.” Read a recent article on challenges with using C language.

Sep

Software Requirements Lifecycle

September 14, 2019Brian PateBlog

For anyone involved in software development, the importance of software requirements cannot be minimized. Software requirements provide the definition and explanation of “what the software should do” and “how the software should behave.” The software engineers and developers use the requirements as input to the software design and coding process. The test developers also use...

Aug

German BfArM Identifies VxWorks Critical Vulnerabilities

August 27, 2019Brian PateNews

Today, the German Federal Institute for Drugs and Medical Devices (BfArM) identified critical vulnerabilities in the Wind River VxWorks real-time operating system. Affected versions of VxWorks are: VxWorks 6.5 to 6.9 (End-of-Life) VxWorks 7 (SR540 and SR610) VxWorks 653 MCE 3.x (may be affected) They pointed out that VxWorks is used in many medical devices....

Aug

FDA Expectations for Requirements

August 6, 2019Brian PateBlog

Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them. The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area. Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...

Jul

FDA Cybersecurity Committee Meeting

July 2, 2019Brian PateNews

Patient Engagement Advisory Committee Meeting to Discuss Cybersecurity – September 10, 2019 On September 10, 2019 the FDA will hold a meeting of the Patient Engagement Advisory Committee. The committee provides advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. During the meeting the...

Jul

MHRA Safety Alert – Hemodialysis

July 1, 2019Brian PateNews

Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024) Summary Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment....

Jun

FDA Forum for Interoperability Feedback

June 27, 2019Brian PateNews

Join the FDA and NITRD on July 17 for a Listening Session on Interoperability of Medical Devices On July 17, 2019, the U.S. Food and Drug Administration (FDA) and The Networking and Information Technology Research and Development Program (NITRD) will host a listening session on the interoperability of medical devices, data and platforms. During the...

Jun

Insulin Cybersecurity Safety Notice

June 27, 2019Brian PateNews

The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.

Jun

DevOps and SaMD Practices

June 26, 2019Brian PateBlog, Prem

This content is only available to Premium subscribers. See our Subscribe page for information on subscriptions. As more “software as a medical device” (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards. Along with...

Jun

SoftwareCPR June 2019 Newsletter

June 26, 2019Brian PateNews

May and June 2019 was a busy period for software related recalls – there were 28 recalls as you will see later in the Newsletter. As you plan your software quality assurance activities, we encourage review of published recalls and consider what steps you have in your process to prevent similar problems. Onward toward higher...

Jun

ARCOS Project

June 25, 2019Brian PateNews

The US Defense Advanced Research Projects Agency (DARPA) have released a solicitation for the “Automated Rapid Certification of Software (ARCOS)” project. The project goal is to automate system risk assessment based on software assurance. The project recognizes that current practices in this area rely upon human judgement which can be prone to error but also...

Jun

NASA Safety Culture Handbook

June 18, 2019Brian PateBlog

Another useful reference for establishing a safety culture in your software organization. “The purpose of this Handbook is to define the NASA Safety Culture Program and to provide guidance in the development and implementation—sustainment, growth, and practice—of Safety Culture at the Center level. It defines the NASA Safety Culture Model, describes the Safety Culture Survey...

Jun

Software Configuration Management Plan

June 13, 2019Brian PateBlog, Prem

This content is only available to Premium subscribers. See our Subscribe page for information on subscriptions. This template is conceived as a partial example template for a generic small device with embedded real time control. Explanatory comments are included in << comment >>. Other text is example definition that you should replace with your own...

Jun

Software Release Note and Revision History

June 12, 2019Brian PateBlog, Prem

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history. Software Revision Level History Example

May

FDA Pre-Cert Test Plan Recruiting

May 22, 2019Brian PateNews

FDA announced the next phase of its Pre-Cert Test Plan implementation. Pre-Cert refers to the the pre-certification program that FDA’s Digital Health unit has been piloting. The program targets SaMD devices only at this time. This next phase seeks SaMD companies, willing to volunteer, that foresee a De Novo request or 510(k) submission within the...

May

62304-FDA Compliance Training

May 20, 2019Brian PateNews

COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 (Registration closes 5/30/2019) Get 24% off for 4 or more from same company registering with same payment! Registration link: https://events.eventzilla.net/e/62304-and-emerging-software-standards-training-course-2138720953 This three-day course provides a clear understanding of the 62304 standard for medical device software, FDA expectations...

May

62304 Conformance Checklist Tool

May 20, 2019Brian PateBlog

This 62304 Conformance Checklist Tool is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. 62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software. 62304 was created specifically for this type of software – it was not...

May

Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem

May 8, 2019Brian PateNews

A 2015 article providing a review of the factors that contribute to a potentially insecure environment, together with the identification of the vulnerabilities, and why these vulnerabilities persist and what the solution space should look like.

Apr

Does Staff Expertise Affect Software Quality?

April 30, 2019Brian PateBlog

Many years ago, Capers Jones, the software metrics guru, analyzed his database of thousands of software projects for the key factors affecting “real” software quality. “Real” software quality relates to how the software actually performed and how robust in the field. His list in priority order was: Programmer Application (domain) Experience Programmer Technical Experience Reuse...

Apr

Quantitative Imaging

April 26, 2019Brian PateNews

In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for...

Apr

SoftwareCPR April 2019 Newsletter

April 26, 2019Brian PateNews

John F. Murray, Jr, will be teaching at our June 4-6, 2019, FDA and 62304 Software course in Boston. Our course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.

Mar

CBER Finalizes Standards Guidance

March 25, 2019Brian PateNews

The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today. The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...

Mar

FDA Exempts Flow Cytometry from 510(k) requirements

March 14, 2019Brian PateNews

US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements. Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...

Mar

FDA qualifies software module biomarker test

March 14, 2019Brian PateNews

Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies. This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker...

Mar

FDA Medical Device Development Tool (MDDT) Qualification

March 14, 2019Brian PateNews

Medical Device Development Tool (MDDT) Qualification The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices. The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and...

Mar

SoftwareCPR March 2019 Newsletter

March 7, 2019Brian PateNews

Our March 2019 Newsletter has been published. Learn of significant regulatory and standards related activity associated medical device software, medical mobile apps, and HealthIT software. Also you can find dates for upcoming training opportunities.

Feb

Inclusion of URL in Electronic Labeling

February 27, 2019Brian PateNews

For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”. This guidance contains a recommendation: “ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under...

Feb

2019 Edition of 62304 Training

February 25, 2019Brian PateNews

What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience. The topics we plan to cover in our 2019 course are below. Topics: Regulatory...

Feb

FDA recognizes Defect Taxonomy Consensus Standard

February 20, 2019Brian PateNews

On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software. The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies. This standard is lengthy and technical in terms of its approach to defect...

Feb

SoftwareCPR® Subscriptions Information

February 16, 2019Brian PateNews

Through blog posts and downloadable content, Alan Kusinitz, Sherman Eagles, Brian Pate, and other SoftwareCPR® experts keep you informed of new developments in FDA Software Regulation, enforcement actions, ISO standards related to medical devices, and also gain access to a wide variety of training aides, document templates, and checklists! Download the attached form to learn more about the different SoftwareCPR® subscriptions...

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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

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

Registration Link:

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

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

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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