Navigating Cybersecurity for Medical Devices

It is no secret … medical device manufacturers and Health IT groups face a tremendous challenge with cybersecurity.

There are high regulatory and market expectations of activities and documentation. Keeping up with the cybersecurity state of the art requires prioritization and investment. A common complaint we hear is, “navigating cybersecurity for medical devices and medical device software is very difficult!”

While cybersecurity expectations are high, the good news is that there is a lot of help available! FDA guidance and industry standards provide a very clear picture of what is needed.

Do you have any cybersecurity responsibilities?

If so, Brian Pate, SoftwareCPR General Manager and Partner, and I invite you to join our upcoming webinar for an overview of the resources available to you.

The webinar is rescheduled for Monday, July 21, 2025 at 2 p.m. U.S. Eastern time.

We will identify the guidance documents, standards, and technical information reports that provide the full cybersecurity lifecycle picture. We will also show how the key pre- and postmarket activities relate to DHF and submission items.

This webinar is being offered free of charge for this presentation only and is limited to employees of medical device companies.

To register:

Email the following information to training@softwarecpr.com:

  1. First and Last Name:
  2. Company Name:
  3. Job Role:
  4. Email address (company email address, not personal):
  5. If multiple people will be attending, please send above information for everyone.

We will send you the meeting connection information by email.

We look forward seeing you on the 21st!

About the author

Mike Russell helps organizations succeed without compromising speed, quality, or regulatory compliance. His 40+ years of leadership and advisory experience ranges from startups to Fortune 20 companies and national governments. He expertise includes product and software development, cybersecurity, AI, and leadership. Mike served on the AAMI group that created TIR45, Guidance on the use of Agile practices in the development of medical device software. He is also an AAMI expert faculty member for software validation (product and non-product) and agile. For SoftwareCPR, he co-created and delivers training on compliant agile and medical device cybersecurity. As an executive, Mike led organizations of up to 1,100 people with over $100 million budgets.

Upcoming Public Courses

No public courses are planned at this time.

If you would like to discuss a private, onsite course, please fill out the form below.

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

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