Thought Leadership
We don’t just operate in the regulatory space—we help shape it. As pioneers in cybersecurity for medical devices, our influence extends from the engineering bench to FDA guidance. These resources reflect the depth of our expertise and the leadership we bring to a rapidly evolving field.
Why FDA Rejects the Cybersecurity Content of Regulatory Submissions
Harbor Labs Chief Scientist Dr. Avi Rubin identifies some of the most common reasons why the FDA rejects the cybersecurity content of regulatory submissions.
Dr. Mike Rushanan Teaches Groundbreaking Course on Medical Device Cybersecurity at Johns Hopkins University
The Internet of Things has long delivered on the promise of connecting everyday products such as smart thermostats,...
Regulatory Science Meets Cyber Science; Why It’s So Much More than a Pen Test
Anyone who has had professional interaction with the FDA has encountered the term regulatory science. It is used...
Medical Device Manufacturer Must Do’s for Cybersecurity
At Harbor Labs, one of our most common services is reviewing the cybersecurity content of the premarket submissions of...
Medical Systems and Third-Party Smart Devices
It is an increasingly common practice in the medical device industry to integrate third-party smart devices such as...
Why Harbor Labs Supports The CVSS 3.0 Standard For Medical Device Security
At Harbor Labs, we are both advocates and purveyors of the Common Vulnerability Scoring System (CVSS). We include CVSS...
DIY Diabetics and FDA Policy
This past week, I had the opportunity to brief policy analysts from the FDA on the growing Do-It-Yourself (DIY) trend in...
New FDA Guidance On WiFi-Managed Infusion Pumps Is Cybersafe And Cybersecure
I was recently interviewed by a prominent medical publication on my thoughts on the FDA’s new policies on wireless...