Overview
In an era where the medical device industry is increasingly reliant on connected technologies, ensuring cybersecurity compliance has become a critical concern. The FDA’s evolving guidelines on cybersecurity have established stringent protocols for manufacturers to follow, ensuring that devices remain secure throughout their lifecycle. The QualiZeal Whitepaper delves into the importance of these guidelines and provides a comprehensive roadmap for medical device testing to meet FDA requirements.
By offering a clear understanding of regulatory standards, risk management processes, and the necessary testing strategies, this whitepaper serves as an essential guide for manufacturers. It outlines the key elements of the FDA’s cybersecurity framework, including risk assessments, vulnerability assessments, and post-market surveillance. With QualiZeal’s expertise, the document emphasizes best practices for integrating cybersecurity into the design and development phases to prevent data breaches, protect patient safety, and ensure regulatory compliance.
In this whitepaper we cover:
- A detailed overview of the FDA’s cybersecurity guidelines for medical devices.
- Step-by-step guidance for incorporating cybersecurity testing into the device development lifecycle.
- A roadmap for achieving FDA compliance and safeguarding patient data against cyber threats.
