Search Results

The U.S. Food and Drug Administration has issued updated guidance on cybersecurity requirements for medical device premarket submissions, aligning more closely with current quality management system standards, emphasizing lifecycle risk management, and encouraging manufacturers to adopt secure product development frameworks.

The FCC has reversed a January ruling that would have held telecom carriers legally accountable for cybersecurity protocols, sparking internal dissent. Commissioner Anna Gomez warned the reversal "leaves the country less secure" amid rising threats, while the Commission cited other recent security initiatives.

New harmonized EU cybersecurity standards EN 18031-X took effect August 2025, requiring radio equipment manufacturers to conduct risk assessments across three overlapping standards. Despite similar requirement codes, critical differences in text and restrictions can impact compliance strategies.

As connected medical devices become more integral to patient care, ensuring their cybersecurity is critical to both patient safety and regulatory compliance. This article explores how the IEEE 2621™ standard and its associated certification program provide a structured, standards-based approach for engineers to design, validate, and secure these devices throughout their lifecycle

Achieving a balance between effective cyber protection and free trade can present multiple challenges. In this article, we outline recent and upcoming cybersecurity protections that are being enacted in the U.S., Canada, the European Union (EU), and other jurisdictions.

The European Union’s 2024 Cyber Resilience Act makes complying with the cybersecurity standards in the Radio Equipment Directive (RED) mandatory. Your firmware developers may need a significant amount of time to implement the provisions, so if you have not already started securing your product to the new regulation, you need to do so now.

The U.S. National Institute of Standards and Technology (NIST) has released an updated version of its Privacy Framework in an effort to better align it with its Cybersecurity Guidelines.

The U.S. National Institute of Standards and Technology (NIST) has released for public comment a draft of a Quick Start Guide for its Cybersecurity Framework 2.0.

The FCC and Department of Education have released "Cybersecurity Resource Recommendations," a guide offering cost-effective strategies to help schools and libraries protect their networks from cyber threats and data breaches.

The IEEE Standards Association announced that several testing facilities operated by atsec Information Security have been officially recognized to conduct testing in accordance with the requirements of the IEEE’s Medical Device Cybersecurity Certification Program.