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

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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