PureFDA Revenue and Competitors

PureFDA, a unique CRO with SaaS + Data service, provides regulatory compliance consulting to medical device and IVD companies globally. We assist with medical device registration/approval, regulatory strategy, local in-country representation, and post market surveillance in 30+ markets worldwide. With subsidiaries in North America, Europe, and Asia, we offer our clients global market insights and one-stop GMA (Global Market Access) solutions. PureFDA @ US PureID @ China 普瑞纯证 PureClinical @ Europe ➤ Certification Service: Our network of certification experts provides full-scale certification service in the U.S. as well as throughout the European Union, Australia, Brazil, Canada, China (including Hong Kong and Taiwan), Colombia, South Korea, Costa Rica, India, Israel, Japan, Malaysia, Mexico, Saudi Arabia, Singapore, etc. ➤ Global registration and local in-country representation: We serve as the registered Agent for the US, UK, Germany, Netherlands, Spain, etc. FDA 510k and EU IVDR, MDR are our expertise. ➤ CRO: Pure Clinical, the European CRO under PureFDA, has 7 top compliance clinical laboratories across Europe and North America, which can provide clients with exclusive IVDR clinical trials. ➤ Global Regulatory Intelligence: We have developed the exclusive Global Regulatory Intelligence Platform (GRIP). This platform provides users with market access information in 30+ countries, 200,000+ global distributors, 200,000+ clinical records, 3 million+ global medical device registration information.