Implementing a Quality Management System for Medical Devices and In Vitro Diagnostics

This webinar is intended to help you get familiar with US quality system regulations and how to implement an FDA-compliant quality management system for medical devices including in vitro diagnostic medical devices (IVDs).  Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control.  Accurate understanding, interpreting, and implementing applicable requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving an enormous amount of your unnecessary time, efforts and investment in many areas of manufacturing and business operations.This webinar will provide guidance (e.g., current good manufacturing practices) on how to establish an adequate quality management system for medical device industry and follow it.