Monthly Archives: January 2022

From software as a medical device, to the growing field of biologics, to the enhancement of medical devices with medicinal substances, the scope of products considered combination products continues to expand.   Join industry-renowned instructor Susan Neadle to deepen your understanding of the ever-evolving regulatory landscape of combination products, including navigating and applying requirements and [...]

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that [...]

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how [...]