Ensuring Reliable Laboratory Testing Data in Premarket & regulatory Submissions

Ensuring Reliable Laboratory Testing Data in Premarket & regulatory Submissions

Are you involved in selecting and qualifying test labs for your medical device? Join us for an insightful webinar where we’ll dive into the critical topic of ensuring reliable laboratory testing data for your medical device submissions. This collaborative session, hosted by TÜV SÜD, features experts from both TÜV SÜD and MCRA, an IQVIA business. 

Key topics:

Introduction

• Understand the importance of reliable lab testing data and the FDA’s recent letter to the industry.

Case Study Review

• Explore instances of improbable and fraudulent data and learn from the consequences faced by manufacturers.

How to Best Qualify Test Labs

• Discover key criteria for selecting test labs, verification processes, and how to spot red flags.

Key Takeaways

•  Insights to ensure the integrity of laboratory testing data.

Speakers:

Danny Oseid - Product Expert - Biocompatibility and Regulatory Strategy Coordinator at TÜV SÜD

Sue Latham - Vice President of Clinical Quality Assurance at MCRA, an IQVIA business

Robert Allen - Director, Regulatory Affairs - Biocompatibility at MCRA, an IQVIA business

Shannon Carver – Senior Quality Engineer, Team Lead at TÜV SÜD

Data Support:

Christine Laube - Technical Advisor at TÜV SÜD