Blog Archives

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

Jun

June 2019 Standards Navigator Report

June 4, 2019Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on...

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

FDA Final Guidance Q-Submission Program

May 8, 2019Alan KusinitzBlog

Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019). The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In our opinion, early feedback and...

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...

Mar

March 2019 Standards Navigator Report

March 22, 2019Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...

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

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

New Approach for Health Canada

January 24, 2019Amy SellersBlog

Health Canada has recently provided a new approach for device approval as outlined in their “Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality.” Canada classifies medical devices based on their potential risk, with Class I devices being lowest-risk and Class IV devices presenting the highest risk. The collaborative new approach aims to...

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

December 2018 Standards Navigator Report

January 7, 2019Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software It appears that in response to a question posed by the IEC 62304 working group, the ISO and IEC member countries want ISO 14971 to be required for use of the second...

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

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

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

62304 Second Edition Questionnaire

November 13, 2018Alan KusinitzBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304. 62304 Edition 2 Questionnaire

Nov

62304 Second Edition Presentation

November 13, 2018Alan KusinitzBlog, Prem

This content is only available to our Premium subscribers. A presentation on IEC 62304 Second Edition may be found at the following link: IEC 62304 2nd Edition Presentation

Nov

October 2018 Standards Navigator Report

November 11, 2018Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software Two webinars were held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management and...

Sep

All Recall Excerpts from Jan 2015 – present

September 26, 2018Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review,...

Sep

Warning Letter Excerpts – Jan 2014 to Sep 2018

September 26, 2018Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this...

Sep

August 2018 Standards Navigator Report

September 7, 2018Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Standards and Regulatory Activity Overview Medical device software Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management...

Aug

FDA Regulation of Mobile Medical Apps

August 1, 2018Amy SellersBlog

The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...

Jul

FDA Benefit-Risk Analysis Summary

July 29, 2018Amy SellersBlog

What concerns FDA when conducting a benefit-risk assessment of medical devices? The answer is a long list of variables that can vary by type of device, target population, and indications for use, but the clear focus is on patient safety and benefit. The FDA considers both the device benefit-risk assessment, as well as evidence and...

Jul

FDA Software Precertification News

July 27, 2018Amy SellersBlog

Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...

Jul

JAMA Article by FDA Staff – Summary

July 17, 2018Amy SellersBlog

Jul

Standards Navigator 2018 June/July Report

July 1, 2018Sherman EaglesBlog, StdNav

Here is the report for June/July, 2018. SoftwareCPRStandardsNavigatorReportfor2018-07

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

Mar

Standards Landscape March 2018 Update

March 16, 2018Sherman EaglesBlog, Prem

This update addresses International and US National medical device standards ("a view of the landscape") being developed or revised that may be of interest to developers of software for medical devices or healthcare. Some of these standards are used directly for regulatory purposes and others may be valuable in demonstrating to regulatory authorities that a...

Mar

Production and Process Validation

March 14, 2018Alan KusinitzBlog

This content is only available to Premium level and Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR has prepared a collection of production and process validation material suitable for training in Production and Quality Systems 820.70(i) Validation including Part 11. Portions could be made into handouts or provided electronically. Download the manual...

Dec

FDA Least Burdensome Principles Draft Guidance

December 14, 2017Amy SellersBlog

On Dec. 14, 2017, the FDA released a Draft guidance dated Dec. 15, 2017 “The Least Burdensome Provisions: Concept and Principles.” This guidance discusses FDA’s intent and approach to applying Least Burdensome Principles to the total product lifecycle for medical devices based on requirements in FDAMA (Public Law 105-115), the FDA Safety and Innovation Act...

Nov

SCPR Standards Landscape Nov 2017 Document

November 6, 2017Sherman EaglesBlog, Prem

Summary of primary medical device standards as well as standards specific to Medical Device and Health IT software

Oct

FDA MDDS – Still Confusing After All This Time

October 31, 2017Alan KusinitzBlog

FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...

Oct

Retrospective Validation

October 17, 2017Alan KusinitzBlog

I don’t even really like to use the word retrospective

Sep

Agile Methods in Medical Device Companies

September 26, 2017Paul FeltenBlog

A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors...

Aug

A Collaborative Approach to Test Debt

August 30, 2017Paul FeltenBlog

Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...

Jul

Cybersecurity issue related to Amazon Cloud

July 31, 2017Paul FeltenBlog

A security company indicated the following: … many companies received emails from Amazon indicating that their AWS S3 bucket policies were left configured as “publicly accessible”. These publicly accessible policies allow potentially sensitive cloud data exposed to cybersecurity threats, and likely are not the intention of the Amazon customers. Amazon recommended that each “bucket” policy...

Jul

TIP: Cybersecurity and Risk Control

July 26, 2017Alan KusinitzBlog

Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®: Cybersecurity vulnerabilities can have unpredictable effects on safety. Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar. That concept is explained in relation to...

Jul

July 2017 Standards Landscape Status Update

July 15, 2017Sherman EaglesBlog, StdNav

This document provides Sherman Eagle's June 2017 standards status update to be used with the Standards Landscape document. It provides a summary of status updates to primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards.

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:...

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...

Feb

Standards Update – 82304, 80002-2, 80001-2-9 Software

February 16, 2017Sherman EaglesBlog

Although IEC 82304-1 Health Software: General requirements for safety has been published it is not clear when it will be harmonized in the EU. Nonetheless it appears EU notified bodies are treating it as “state-of-the-art” and are likely to expect it to be used for software products that are regulated as medical devices. IEC TR...

Jan

IEC 82304 Health Software Checklist

January 18, 2017Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR checklist for "IEC 82304-1: Health software - Part 1: General requirements for product safety." Download: IEC 82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device...

Jan

$Jan 2017 SoftwareCPR Standards Landscape$

January 17, 2017Sherman EaglesBlog, StdNav

This content is only available to Standards Navigator and Standards Navigators PLUS subscribers. See our Subscribe page for information on subscriptions. This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how...

Jan

January 2017 Standards Landscape

January 15, 2017Sherman EaglesBlog

This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how the standards will impact the development of medical device and Health IT software. This is truly a MUST READ...

Aug

$Part 11 Warning Letter Excerpts in one pdf file$

August 26, 2016Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. The attached pdf file contains all Part 11 related warning letter excerpts included on this site as of the date above. This file is updated periodically, but for the most recent warning letters between these updates, do text...

Jun

$Draft Health Code of Conduct$

June 20, 2016Alan KusinitzBlog, StdNav

This document is the result of an industry-led initiative of the European Commission. It is targeted at app developers and its purpose is to foster justified trust among users of mHealth apps which process personal data. Standards Navigator Draft Health Code of Conduct

Mar

$SCPR 62304 Checklist Revised for Amendment 1$

March 22, 2016Alan KusinitzBlog, Prem

The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.

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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: June 5-7, 2024
Boston, MA

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

Registration Link:

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: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

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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