Marie Dorat, CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; GCP, Supplier Qualification, Audit, CAPA, and Master Validation Programs. MS. Dorat has worked with Implantables, Wearables, Vaccines, IVDs, Medical Devices with software as well as Software as a Medical Device and mobile application devices. She has also published articles on various GxP subjects