Timely, insightful, and relevant thoughts, opinions, and discussion on FDA software validation, 62304 compliance, medical device software standards, updates impacting medical device and HealthIT software development, and sundry subjects from our Partners and staff.

Use of master files can be a convenient and strategic method for SaMD manufacturers or software suppliers to provide information necessary for a US regulatory submission without disclosing confidential and/or proprietary trade secrets to business partners. For example, a software supplier of a cloud library providing medical device functionality could submit a master file to...
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I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...
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One of the cornerstones of a quality management system is the integrity of the quality system records. It should go without saying how critical it is for these records to be truthful, accurate, and genuine. Fraudulent data can lead to an unsafe medical device, or a medical device that does not fully achieve its intended...
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Solving Problems Another great “soft skill” I learned from a mentor early in my career was knowing when to ask questions. You know, how long should I dig, research and investigate, before seeking the help of others? Some may gravitate toward spending too much time trying to find answers or solutions when it would have...
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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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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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The US regulations for design controls have requirements for design and development planning.  In fact, a design and development plan is an indication that a manufacturer has “exited” research phase activities and entered the development phase, and thus, design controls should be in place.  The regulation, 21 CFR 820.30(b), specifically states: Design and development planning....
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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 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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