Standards Navigator Benefits

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 is essential to staying ahead on compliance and remaining “state of the art.”

SoftwareCPR Standards Navigator

One alternative you might consider is an annual SoftwareCPR Standards Navigator subscription.  Our SN subscription provides you with:

  • Annual report on the current status of all pertinent medical device software and health information technology standards and guidance
  • Announcements of new medical device and health information technology software standards and guidance when they are proposed – before they are started.
  • Monthly (or bi-monthly) updates with analysis, reports on medical device software, risk management, and digital health information technology standards and guidance under development or revision
  • Discussions on new draft standards and opportunity to provide input to the standards committee!
  • Up to ten technical and/or regulatory questions via our website

Starting in May 2021, our Standard Navigator subscription has been reconfigured and will now only cost $3,995 per year.  Consider the amount of effort your organization can save by letting our staff do the leg-work of keeping up with the standards that impact medical device and digital health software!

Subscribing is easy!  Just navigate to our subscription page on this website or click on this link:  Subscribe

Not Sure?

Fill out this form and we will send you a recent monthly update so you can view a sample of the information you will with your SN Subscription.

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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 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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