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 Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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