Emergo Group is based in Austin, Texas and provides quality and regulatory compliance consulting to medical device and IVD companies. The company assists with US FDA 510(k) clearance, CE Marking for Europe, plus medical device approval in Canada, Japan, China, Mexico, Brazil, Korea, India, Russia and Australia. The company also assists with medical distributor search. Offices in North America, Europe, Asia and Australia.

Specialties

Medical device regulatory consulting, FDA 510(k) approval, CE Marking, ISO 13485, FDA GMP, medical distributor search

Emergo Group is an ISO registered medical and IVD device consulting firm with offices in the USA, Canada, Mexico, Brazil, France, Germany, UK, Netherlands, Russia, China, Japan and Australia.