Navigating Cybersecurity Compliance: A Lifecycle Approach for Medical Device Manufacturers

This whitepaper outlines the medical device software lifecycle processes and details the necessary documentation and activities required to meet newcybersecurity requirements. We will cover best practices for integrating cybersecurity throughout the medical device lifecycle, from design to post-market management. Key global regulatory expectations from the FDA and EU will be highlighted, along with insights into common challenges that result in approvalrejections. Additionally, the document will include examples of regulatory body responses and real-world feedback from the past year, guiding manufacturers toward improved compliance and enhanced product security.