Optimization for Global Vigilance Reporting

Vigilance reporting plays a critical role in the safety of medical devices in use around the world. However, navigating the complex regulatory requirements in different countries can be challenging. Missing deadlines or submitting incomplete reports can lead to delays, increased regulatory scrutiny, or even penalties. This webinar will provide practical insights to help your organization stay compliant and efficient in its reporting.

Key takeaways from this webinar are:

• Differences and similarities in reporting requirements
• Strategies to increase on-time reporting
• Minimize regulatory inquiries

About the presenter

Elizabeth Pugh, Manager, Quality & Regulatory Affairs Program 

Elizabeth Pugh has been with EMERGO since 2011 and has over 14 years of industry experience, primarily focused on orthopedic devices, including implantable devices. Elizabeth’s background includes CERs, global vigilance reporting, 510(k) clearances, EU Technical Documentation Files, participating in risk management files, global regulatory strategy and performing international regulatory research. Elizabeth manages Emergo’s vigilance activities in the EU, UK, US, Australia, Singapore, Malaysia and other markets. She has reviewed and submitted over 5,000 vigilance reports. Additionally, Elizabeth utilizes her regulatory background to complete a wide range of projects for Emergo clients such as technical file compilation, clinical evaluation reports, 510(k)’s, regulatory research and regulatory strategy reports.