Emergo Group helps medical device companies obtain regulatory approval to sell their products in the largest medical device markets worldwide. Services include US FDA 510(k) submissions, CE Marking approvals, ISO 13485/FDA GMP implementation, Japan PAL compliance, China SFDA approvals, Health Canada license approvals and distributor search consulting. Offices in the USA, Europe, Japan, China, Australia and Canada. Since 1997.
Keywords: medical device consulting, FDA approval, FDA 510(k) submissions, CE Marking approvals, ISO 13485, FDA GMP implementation, Japan PAL compliance, China SFDA approvals, Health Canada license approvals, medical distributor search