Brian Pate, Author at SoftwareCPR

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Brian Pate

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...

Feb

Software Controlled Trucks Crash

February 15, 2019Brian PateBlog, Prem

The West Australian reported that two autonomous haulage systems (AHS) trucks experienced a collision when one of the trucks backed into the cab of the second truck that was stationary at the time. This is of interest to us as the AHS trucks are software controlled and they crashed. Clearly a failure mode. The initial report is...

Feb

The Software Commandments

February 13, 2019Brian PateNews

Came across this website that has some very detailed “commandments” for software development at their company. A surprisingly lengthy list of dos and don’ts related to coding, testing, designing, estimating, and managing the software lifecycle. Does your company have anything written? I often find that each company has some “lore” – some practices that characterize...

Feb

FDA Least Burdensome Final Guidance

February 5, 2019Brian PateNews

The US FDA issued the final guidance for industry, “The Least Burdensome Provisions: Concept and Principles.” This guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles. FDA Least Burdensome Final Guidance

Feb

Learning from FDA Safety Communications

February 2, 2019Brian PateBlog, Prem

FDA issued a Safety Communication on January 31, 2019, (see Safety Communication Link) warning of the risk of air being introduced in a blood vessel (air-in-line) and air embolism for infusion pumps, fluid warmers, rapid infusers, and accessory devices. This communication is directed toward users (both clinical and service personnel) and patients. However, what can system architects,...

Jan

Can Agile Methods be used for Medical Devices?

January 30, 2019Brian PateNews

Does FDA accept regulatory submissions for medical devices and SaMD that have software developed using agile methods? What about IEC 62304 compliance? Can agile and lean approaches to software development be compliant? On February 18th and 19th, 2019, we will explore those topics and more at our 2019 “Being Agile & Compliant” public training course. ...

Jan

Being Agile … & Compliant – Feb 18-19, 2019 Public Training Course

January 21, 2019Brian PateNews

COURSE DATES: February 18 – 19, 2019 TRAINING LOCATION: Tampa, Florida, USA COST: 2 Full Days for $2,495.00 January Registration Discount of 10% available through Jan 19, 2019. Extended to 1/25/2019. Ask about our multi-student discount as well! Meet our newest partner, John Murray, at the course! Download registration form Only a limited number of...

Jan

Verily Study Watch receives 510(k) clearance from FDA

January 18, 2019Brian PateBlog

The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems. The idea is that the Verily watch would be worn similar (or as!) a consumer device...

Jan

John F. Murray, Jr, joins SoftwareCPR as a partner

January 7, 2019Brian PateNews

(January 7, 2019)— John F. Murray, Jr, of Mount Airy, MD USA, has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a partner. John retired from the US Food and Drug Administration in December 2018 after 32 years of federal service. For 25 years at FDA, John focused on FDA regulated software and...

Dec

The Essence of Design Input

December 24, 2018Brian PateBlog

Clearly one of the great struggles with medical device product design is to understand and finely tune the design input for our devices. It is difficult but the payoff can be great when done well – pays off with development efficiency, greater certainty with safety risk control, and ultimately in customer satisfaction. In our training...

Dec

Quick link to US FDA 21CFR820

December 24, 2018Brian PateBlog

It is always good to remind ourselves of exactly what the regulation says – often our corporate procedures can become “bloated” and lead some to believe that some specific activities and/or types of deliverables are required by the regulations.

Dec

Product requirements vs Software requirements

December 14, 2018Brian PateBlog, Prem

One of the most difficult challenges for medical device and HealthIT manufacturers is to properly "level" the design requirements for their medical device systems such that it is clear when it comes to design validation versus design verification.

Dec

New FDA Guidance – X-Ray

December 14, 2018Brian PateNews

FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018. A few things to note related to software: On line 370, question 16, FDA addresses the question of the use of software...

Dec

Good Cyber Hygiene

December 14, 2018Brian PateBlog

Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing...

Dec

FDA Draft Guidance Prescription POC

December 11, 2018Brian PateNews

FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...

Dec

Another Warning Letter … and we still miss software validation

December 6, 2018Brian PateBlog

Glanced through the latest FDA warning letters today. From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.” Of course this is...

Nov

Prescription Drug-Use-Related Software

November 28, 2018Brian PateNews

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital...

Oct

FDA Final Risk Guidance – Different Technologies

October 11, 2018Brian PateNews

FDA released a final guidance "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications 510(k) with Different Technological Characteristics" dated Sept. 25, 2018. This guidance applies only to devices with similar intended use and if the different technological characteristics do not raise different questions of Safety and Effectiveness. Read the full guidance at...

Oct

FDA CDRH 2019 New Guidance Plan

October 6, 2018Brian PateNews

FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...

Aug

Warning Letter – Lack of Data Integrity

August 29, 2018Brian PateNews

Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...

Jun

Recall – Apollo Anesthesia Machine

June 27, 2018Brian PateNews

Company: Draeger Medical, Inc. Date of Enforcement Report: 6/27/2018 PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification....

Mar

Software Standards and FDA Guidance Visual Aid

March 23, 2018Brian PateBlog

Prepared a visual aide (one of many we use in our training courses) of key Medical Devices Standards and FDA guidance related to software. Enjoy! SoftwareCPR Sw Stds Guidances

Aug

FDA Digital Health Precert Meeting Summary

August 3, 2017Brian PateNews

"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"

Jun

Security of Medical Devices

June 6, 2017Brian PateBlog

Cybersecurity firm Sophos published an article on Medical Device cybersecurity and David Overton of SoftwareCPR® suggested we post this as it may be of interest. David pointed out these statements: A significant percentage of medical devices are not secure. Most medical device manufacturers do not take serious steps to secure their devices for two reasons:...

May

21 CFR Part 11

May 9, 2017Brian PateNews

We help you meet the intent of the rule -- not the hype

Apr

62304-82304 requirements comparison

April 24, 2017Brian PateBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Created a job aide which compares the IEC 62304 and IEC 82304 elements for requirements. This is only intended to be used as a starting point and requires interpretation based on knowledge of each standard and the type of...

Apr

SW Development Environment Worksheet

April 18, 2017Brian PateBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Use this as a starting point to gather information on the software development environment (and related information) as required in FDA's Guidance for Software Information to be included in open market submissions. It is only intended as a starting...

Nov

$SoftwareCPR Go-Live Checklist Training Example$

November 11, 2015Brian PateBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. A sample checklist for releasing or updating software is at the link provided. GoLiveiChecklistTrainingExample111115 . . . Thank you for your interest! To view our Premium or Standards Navigator content, please click here to select the plan that best...

Jul

Cybersecurity for Medical Devices

July 27, 2014Brian PateNews

Brian Pate of SoftwareCPR® writes: In May 2014, FDA offered further guidance to manufacturers regarding premarket submission information identifying cyber-security risks and hazards associated with their medical devices, and the responsibility for engineering appropriate risk controls to address patient safety and assure proper device performance. FDA encouraged manufacturers to report any cyber-security incidents that may...

Dec

Understanding the Value of Unit Testing

December 8, 2013Brian PateBlog

Obviously, unit tests have their greatest value at the time of the development of the unit itself. Well-designed unit tests provide evidence that the unit performs its intended function, that the software design executes as intended, and allows the developer (or tester) to test the unit with inputs and states that may be difficult to...

Apr

IEC/TR 62348 Assessment

April 8, 2013Brian PateNews

IEC/TR 62348 is a technical report that assesses “the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition.” The report is intended to be a tool for manufacturers to understand the impact of Amendment 1:2012 changes to 60601-1 from the...

Aug

SoftwareCPR Risk Management Training Example 1$

August 3, 2008Brian PateBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed. This example is modeled on the approach required by ISO 14971 and expands on it with...

May

HIPAA Privacy and Security Roadmap

May 14, 2003Brian PatePrem

We hope you find this Regulatory Roadmap on HIPAA Privacy and Security useful.

Feb

HIPAA Privacy Rule effective in less than 3 months

February 5, 2003Brian PateNews

Although the HIPAA Privacy Rule directly effects “Covered Entities” medical device and pharmaceutical manufacturers may be involved in inadvertent release of private patient information and must deal with requirements from their customers that are Covered Entities. It was reported that: Eli Lilly, already has settled with eight states and the Federal Trade Commission for $160,000...

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

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

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

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

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

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

Registration Link:

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