Harbor Labs Director of Firmware Security Dr. Paul Martin describes the strategies, tools, and methodologies used at Harbor Labs when performing source code comparisons in support of litigation consulting and investigation engagements.
Dr. Paul Martin describes the strategies and computer science disciplines involved in performing a code quality assessment, and how these processes can be used to produced a defensible, evidence-based conclusion on the coding quality of a target codebase.
Harbor Labs Chief Scientist Dr. Avi Rubin identifies some of the most common reasons why the FDA rejects the cybersecurity content of regulatory submissions.
HarborLabs CEO Nick Yuran distinguishes cybersecurity from cyberscience, and explains why understanding the shared scientific disciplines of regulators and security professionals are important in achieving positive regulatory outcomes.
Harbor Labs Director of Medical Security Dr. Mike Rushanan provides a comprehensive outline of the cybersecurity must-do’s necessary to meet regulatory approval. Based on years of experience working with the FDA and other regulatory bodies, Dr. Rushanan’s blog provides insights into the common pitfalls that can disqualify or delay regulatory approvals.
This white paper presents basic guidelines for source code reviews to assist litigation teams in negotiating the terms of protective orders, to improve cost estimates, and to enable technical experts to streamline their analysis.
This white paper addresses best practices for ensuring cybersecure and cybersafe medical device design to mitigate the risk of compromise or misuse.
Your Protective Order could set the stage for a successful code review and case or a long, arduous process. How do you ensure your analysts have the best access and avoid hardships as they look to help build your case?
As part of our Medical Device Security services, HarborLabs assisted a leading manufacturer to help resolve a security issue that was impeding regulatory approvals and corporate business objectives. Learn more about this case and our services.
As part of our Medical Device Security services, HarborLabs was contracted by a manufacturer of a specialized surgical robotics system to conduct a pre-market cyberthreat analysis in support of their 510(k) submission. Learn more about this case and our services.
