About This Webinar

Ensuring timely and compliant regulatory submissions remains a challenge for global medical device companies. Rejected submissions result in unforeseen costs and negatively impact planned product launches and device market availability.

Join us on November 29 at 1:00 pm PST for a live webinar with Dr. Victoria Samonte, Medical Director, Global Medical Operations at Abbott Diagnostics division and Dr. Bassil Akra, Founder & CEO at AKRA Team GmbH, moderated by Michelle Zaharik, President at MLZ Biotech Consulting. They will discuss the challenges and opportunities related to software implementation and evidence management for medical devices leading to confident regulatory submissions.

Key Learning Objectives:

• Achieving confidence in regulatory submissions for a faster path to compliance.
• Assessing literature review data quality.
• Implementing continuous and efficient evidence management practices from pre-market approval through post-market surveillance.
• Leveraging standardized and repeatable processes for audit-ready literature reviews.