September 5, 2024 – In collaboration with MedTech Leading Voice, Marcus Engineering announces the release of its latest eBook, “MedTech Consultant’s Guide to Cyber Device Regulation: A Global Perspective.” This guide, co-authored by industry experts Eric Henry, Mark Omo, Richard Koch, and Lina Ramirez, offers fresh insights into critical risk and security aspects of medical devices.
In response to the escalating cyber threats and changing regulatory requirements facing the medical device industry, Marcus Engineering, a leader in medical device engineering, has just released its new 24-page eBook, “MedTech Consultant’s Guide to Cyber Device Regulation: A Global Perspective.”
Authored by four industry experts, this essential guide thoroughly examines the critical aspects of medical device cybersecurity, providing invaluable insights for MedTech professionals.
“As cybersecurity threats continue to evolve, so too must our understanding and preparedness,” said Mark Omo, Engineering Director & General Manager at Marcus Engineering.
“This eBook goes beyond summarizing the viewpoints from our recent Cyber Device Summit. It is a vital resource, equipping MedTech professionals with the knowledge and tools needed to navigate the complex landscape of global cybersecurity regulations.”
Chapters in the eBook Include:
Chapter 1: What You Need to Know About Medical Device Cybersecurity: US Regulatory Considerations
Eric Henry, Senior Quality and Regulatory Advisor at King & Spalding, examines the intricate US regulatory framework, covering essential guidelines and standards, including FDA premarket and postmarket requirements. The chapter also addresses common compliance challenges and offers best practices for integrating cybersecurity into design controls and risk management.
Chapter 2: Engineering Secure Medical Devices: Addressing Key Vulnerabilities
Mark Omo, Engineering Director and General Manager at Marcus Engineering, uses relatable analogies to explain the importance of securing every potential entry point in a device, much like locking doors and windows in a home. It highlights threat modeling, risk assessment, and the necessity of maintaining a comprehensive Software Bill of Materials (SBOM) to manage third-party software risks effectively.
Chapter 3: Europe’s Evolving Cybersecurity Standards
Richard Koch, Founder and Consultant of Koch SaMD GmbH, outlines the significance of the EU’s cybersecurity framework in this chapter, discussing key regulations like the NIS Directive and GDPR. He emphasizes the need for efficient Design and Development Operations (DaD-Ops) to ensure compliance and secure device development.
Chapter 4: Navigating the Latin American Regulatory Landscape
Lina Ramirez, Owner and Consultant at Lucid RA, provides a detailed exploration of the diverse regulatory frameworks across Latin America, focusing on aligning with international standards such as IMDRF guidelines and Brazil’s RDC 657/2022. This chapter is essential for understanding how to achieve cybersecurity compliance in this rapidly developing region.
The “MedTech Consultant’s Guide to Cyber Device Regulation: A Global Perspective” is now available for free download here. This eBook is an indispensable resource for MedTech professionals looking to enhance their cybersecurity practices and ensure compliance with global regulations.
Marcus Engineering specializes in the design and development of secure medical devices. Committed to advancing cybersecurity in the MedTech industry, Marcus Engineering offers comprehensive solutions to help manufacturers meet regulatory standards and protect patient safety.