With the increasing frequency and severity of cyber threats targeting healthcare systems, it has become critical to ensure the cybersecurity of medical devices.
The FDA, recognizing the evolving risks, issued a new draft of the “Quality System Considerations and Content of Premarket Submissions” guidance in April 2022, which aims to strengthen cybersecurity requirements for medical devices.
This guidance is expected to significantly impact medical device development, particularly in terms of cybersecurity considerations for 510(k) pre-market submissions.
In this webinar, we will discuss the proposed FDA cybersecurity guidance, its potential effects on the development and approval of medical devices, and steps manufacturers must take to ensure compliance.
Attendees will gain insights into how these changes impact cybersecurity design, testing, and documentation processes.
What You Will Learn?
- An overview of the FDA’s new cybersecurity guidance for medical devices
- How the guidance affects the medical device development process
- Cybersecurity considerations for 510(k) pre-market submissions
- Best practices for incorporating cybersecurity into medical device design and testing
- Steps to ensure compliance with the new FDA standards and maintain device cyber safety
Why You Should Attend This Webinar?
Understanding and meeting FDA cybersecurity standards is crucial for medical device manufacturers seeking pre-market approval.
If you don’t follow the rules, you might face holdups in getting your product approved, have to pull items off the market, or even put patients at risk.
This webinar can help you figure out if your medical devices and applications meet the necessary cybersecurity standards for FDA approval.
Key Learning Points
- The impact of the FDA’s new cybersecurity guidance on medical device development
- Requirements for 510(k) pre-submissions and pre-market approval (PMA) processes
- Strategies for designing and testing medical devices to ensure cybersecurity
- Understanding how cybersecurity incidents can disrupt healthcare systems and patient care
- How to prepare and submit comments to the FDA during the guidance comment period
Don’t miss this opportunity to stay ahead of regulatory changes and protect your medical devices from cybersecurity threats.
Click Here To Register!
