Tag

62304
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...
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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...
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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...
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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...
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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...
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This September 2021 Standards Navigator Report 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, our report keeps you...
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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...
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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....
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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...
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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:...
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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...
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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...
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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,...
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I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between...
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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.
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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...
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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...
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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...
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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...
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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...
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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.
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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
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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 and corresponding general aspects for medical devices. These webinars are being held to explain the status of the IEC 62304 project. A committee...
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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...
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A committee draft for vote of “IEC 62304 Ed 2: Health Software – Software life cycle processes” has been circulated for ballot. Edition 2 expands the scope of IEC 62304 to include health software that is not regulated as a medical device, and the title has been changed accordingly. This will be the last opportunity...
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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...
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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...
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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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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains a training aid that provides an overview comparison between the 2015 Amendment of IEC 62304 and FDA requirements based on 62304 Safety Classes. SCPRed_SoftwareCPR-FDA-62304SafetyClasscomparisonTrainingAide
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The first amendment to IEC 62304 amendment has been published as Edition 1.1. You can purchase just the amendment, which notates what has changed, or a consolidated redline version. It is currently available from ANSI or IEC. AAMI will publish it in the near future, although it may be expensive to purchase from AAMI. This amendment mainly focuses...
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This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. In SoftwareCPR training classes on IEC 62304 and FDA regulation, we sometimes use a fabricated example of a vertical slice of software documentation. This example includes requirements specification, risk analysis, design, and testing along with commentary for one functional...
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This document provides answers to questions that have been asked to notified bodies regarding using EN 62304 for regulatory purposes in the EU. FAQ 62304
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IEC SC 62A has agreed that the 2nd edition of 62304 will be expanded to cover all Health Software, not just medical devices. In the interim, an amendment will be issued to clarify current safety classification as well as application of 62304 for legacy software (this was originally intended to be done as part of...
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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...
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The first committee draft of the second edition of “IEC 62304 Medical device software life cycle processes” has been circulated internally for comment. Major changes include a revision of how software safety class is determined, which could reduce the tendency towards most software being Class C; clear requirements for legacy software that explain how conformance...
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The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains selected templates used in SoftwareCPR training on medical device software standards focused on IEC 62304. These are not intended to be ideal for all situations or comprehensive but are intended to serve...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached zip file contains 3 training templates. One is for an example software development SOP, one is a companion software development plan, and one is a template for software risk analysis incorporating the concept of predefined categories of...
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SoftwareCPR Training Courses:

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:

Register Now

 


 

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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