Good Cyber Hygiene

good cyber hygiene

Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing devices that will be networked.

  1. Use a firewall and periodically maintain its configuration
  2. Change those vendor supplied defaults for usernames, passwords, identifiers, etc.
  3. Encrypt data at-rest and in transport. It’s just too easy to always protect data. Just do it.
  4. Use anti-virus software on development systems, test systems, and other systems that “touch” the product
  5. Install vendor supplied security patches
  6. Limit access to data – de-identify data early in the process.
  7. Obviously, use unique IDs for authentication and add something that is not obvious, e.g., 4 digit number added to first name and last name
  8. Restrict access to physical locations where data is retained
  9. Manage users, both incoming and termination, and monitor activity
  10. Periodically test security layers and re-assess acceptability
  11. Create policy in addition to procedure for security expectations for employees and sub-contractors
  12. Any cybersecurity expectations of our customers/users should be clearly communicated in product labeling

FDA has provided two guidance documents (find them on our Popular Resources page) and there are standards and technical reports that can be helpful as well.  Here are a few that we recommend:

Our partner Sherman Eagles provides periodic updates on standards and technical reports affecting medical device systems and software, and also provides a unique, one-of-a-kind concierge-level mentoring.  See our subscription options to start receiving Sherman’s updates today and engage with Sherman to raise your quality system bar!

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: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.