Dr. Mukesh Kumar - Pharma & Biotech, is a nurse attorney, a medical legal consultant and the former Chief Learning Officer for the Emergency Medicine Patient Safety Foundation. Currently, she serves as President for Patient Safety and Health Care Education and Consulting. In the past, Sue has worked as director in hospital patient safety and risk management for The Doctors Company and was a medical malpractice defense attorney for many years. She was also the director of risk management for the Ohio Hospital Association and has worked in varied roles as in-house legal counsel, privacy office and compliance officer.
Avail great savings and get end-to-end guidance on FDA regulations on Import and Export of FDA-regulated products with our 4-in1 Webinar Bundle by certified regulatory affairs professional Dr. Mukesh Kumar.
Why You Need This?
Companies that manufacture medical devices and/or products that are imported or exported in the United States must comply with applicable U.S. regulations before, during, and after importing/export in the U.S. or its territories. In order to import/export medical devices and/or products into the U.S., the product must meet FDA regulatory requirements. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval. AudioEducator’s 4-in-1 Webinar Bundle comprehensively deals with the topics related to FDA Regulations for Importing and Exporting Medical Devices and/or products. This bundle aims to provide manufacturers and importers with all the information and tools necessary for hassle free custom compliance activities and help support the logistics supply chain.