Navigator 2025 - Featuring Cybersecurity in Medical Devices and an Update to ISO 9001 and ISO 14001 standards

The Navigator 2025 newsletter focuses on the evolution of cybersecurity standards across key sectors such as automotive, aerospace, and medical devices. It highlights the growing adoption of IEC 62443 as a comprehensive framework for securing Industrial Automation and Control Systems (IACS), now increasingly used to protect medical devices against cyber threats.

A key feature of this edition is the FDA’s mandate for cybersecurity in medical device submissions, postmarket surveillance, and quality systems—outlining critical requirements for manufacturers.

The newsletter also covers updates to the amendment of ISO 14001 and the ongoing revision of ISO 9001:2015. It includes a case study on TISAX 27001 implementation by an automotive cybersecurity firm, demonstrating improved information security and expanded business opportunities.

Highlights of this Edition:

• Cybersecurity in Medical Devices
• FDA Cybersecurity Mandates
• Updates to ISO 14001 & ISO 9001
• TISAX & ISO 27001 Implementation - Case Study
• Featured Training & Webinars for 2025