Emergo provides quality and regulatory compliance consulting to medical device and IVD companies. We assist with medical device registration/approval, regulatory strategy, ISO 13485 and QMS compliance, local in-country representation and post market surveillance in 20+ markets worldwide. Offices in North America, South America, Europe, Asia, Australia and the Middle East.
Industry
Professional Services, Medical Equipment Manufacturing
HQ Location
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746, US
Keywords
Regulatory strategy and consultingQMS implementation and auditsMedical device and IVD registatioClinical data evaluation and PMCFIn-country regulatory representatioPost market surveillance consulting