Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...
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What does the US FDA expect in a premarket submission for description of the software design?  In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance. For lower risk devices, the manufacturer is not required to...
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Software risk analysis requires consideration of both the development process itself and the runtime environment.
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The recent FDA guidance, Content of Premarket Submissions for Device Software Functions (June 14, 2023), points out that software design is a prospective activity and should not be done in an ad-hoc or last-minute approach.
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#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?
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FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions.  This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...
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(Ann R. Thryft. 11-16-22. Mddionline.com) A team made up of Sensoria Health, Foot Defender, and former Nike shoe designers came together to create a cloud-based patient monitoring boot for Diabetes patients. On the extreme, but very realistic side, this technology could help save patients from requiring an amputation if used correctly after ulcer surgery. The...
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Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 22, 2022) “We are pleased to announce that our Partner and General Manager, Brian Pate, has been selected  for membership on the UL 1998 Standards Technical Panel for Software (STP), with oversight of UL 1998 standard, Software in Programmable Components.  Brian will provide stakeholder input to...
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Just a few thoughts on metrics … specifically software metric.  A software metric defines a standard way of measuring some attribute of the software development process or an attribute of a software component. A software metric allows us to compare and evaluate one process or component with another, and plan to improve quality of a...
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Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...
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Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...
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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...
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In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service –...
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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...
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In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump constructs,...
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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:




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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