With the globalization of the medical device industry, supply chains are getting more rigorous and constantly adapting to the fast-changing distribution environment. The three key challenges to overcome are understanding the global supply chain process, designing safe, protective packaging systems to withstand a multitude of shipping and transportation conditions, and lastly is developing a packaging performance test plan compliant with FDA and/or international health and safety.

We will share insights and a sample test plan focusing on the packaging of medical devices to optimize your time and avoid product development delays. You’ll learn:

• Overview of various testing standards required to get medical devices to market.
  
• Testing to consider for various shipping methods.
• The status and expectations of the FDA and international agencies.
• How to design a test plan to meet supply chain rigors.

Presenter:

Sunny J. Modi, Ph.D. Director, Package Testing Eurofins Medical Device Testing

Dr. Sunny J. Modi is a Director of Package Testing for Eurofins Medical Device Testing with 10 years of experience focusing on creating and testing packaging materials. He specializes in transport simulation, shelf life, and mechanical testing with a thorough understanding of ASTM, ISTA, and ISO testing standard for package integrity testing. Dr. Modi participated in the technical review committee for International Safe Transit Association (ISTA) and a member of Institute of Packaging Professionals (IoPP) and the Association for the Advancement of Medical Instrumentation (AAMI). Dr. Modi earned his Ph.D. and M.S. degrees from The Ohio State University focusing in packaging and composite applications.