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.

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 Thursday, July 17, 2025 at 1 p.m. U.S. Eastern time (1900 CEST, 1800 UK, noon U.S. Central time, and 10 a.m. U.S. Pacific/AZ).

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 17th!

About the author

Succeeding despite relentless change is the goal of 21st century organizations. Mike helps achieve those successes by working with leaders of start-ups to Fortune 20 companies and national governments. His aim is to help them re-imagine and create adaptive, innovative enterprises that increase profitability and value across the quadruple bottom line: customers, employees, owners/shareholders, and communities.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 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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