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educational
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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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...
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A blog post by Brian Pate of SoftwareCPR see the link provided and scroll down. HealthIT and Software as a Medical Device
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SoftwareCPR now has a validation blog at the link provided. ValidationCPR Blog
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AAMI published an article entitled: “Best Practices in Applying Medical Device Risk Management Terminology” in its Spring 2015 Horizons publication. Alan Kusinitz, Founder of SoftwareCPR, co-authored this article and a reprint is provided with the permission of AAMI at the link provided. This is for your personal reference not for wider distribution due to the...
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Stan Hamilton and Brian Pate of SoftwareCPR offer the following tip. As risk managers, we often struggle to draw the line for inclusion of foreseeable misuse. We ask questions like what is credible, and how far must you go? When performing risk analysis, we decide if it is credible enough to list as a hazard...
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/docs/scpred/SoftwareCPRenhanced-V-Diagram1014.png
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Brian Pate of SoftwareCPR suggest that a good rule of thumb is: If differences in the final product, produced by two different development groups using the same specification element, resulted in unacceptable differences in safety or efficacy then it would likely be a “requirement”. Otherwise it is most likely to be a design specification. This...
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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...
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http://www.ibm.com/developerworks/library/j-fuzztest/index.html
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http://wallstcheatsheet.com/stocks/more-apple-iwatch-clues-fda-meeting-and-healthbook-app.html
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Lisa Simone, a biomedical software engineer at FDA, published an article in the Biomedical Instrumentation & Technology Journal (Nov-Dec 2013) with information on an analysis of historical software related recalls using internal information at FDA as well as other sources. The article breaks down the recalls by year and product type. She investigated the years...
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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...
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The document at the link provided is a short checklist for helping ensure or assess requirements quality. It is an educational aid to be used only by knowledgeable individuals and should not be used blindly or considered comprehensive. This was prepared by Brian Pate with input from Alan Kusinitz. RequirementQualityChecklist  
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If sample sizes need to be determined there are many statistical methods and assumptions related to this so decisions should be carefully considered. Two of the most commonly used sample tables are ISO 2859 for attibutes and ISO 3951 for variables.
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This SoftwareCPR.com newsletter lists items added to the website from 7/22/2013 to 10/24/2013. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related web page should...
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The slides from a SoftwareCPR presentation on compliant use of Agile Methods for medical device software development is at the link provided. This was prepared and presented by Brian Pate and Mike Russell and similar slides are used in SoftwareCPR’s public courses. SCPRed_AgileForMedicalDevices-SoftwareCPRpresentation101010
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This SoftwareCPR.com newsletter lists items added to the website from March 26, 2009 to November 9, 2009 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...
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Microsoft announced they have a fix for a bug that causes display of 100,000 when the actual number is 2 to the 65,536. Even with validation this would be difficult to catch in testing unless one happened to pick test cases that included values resulting in exactly 65,536 or 65,535 Information related to this is...
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/Docs/SCPRed/NEBDGPresentationSlides022802GPSV-SW68-Kusinitz.PDF
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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:  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:

Register Now

 


 

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: February 12-15, 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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