Guidance for Changes in a Medical Device - DUPE

With no relief in sight for supply chain issues and sterilization constraints, understanding the options associated with change has become an immediate need in industry. This 3-day focus on fundamentals course will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment. Our topics of focus include navigating Biocompatibility, Packaging and Sterilization changes and addressing the expectations around managing changes.