Medical device consultants since 1997

Emergo Group has helped hundreds of medical device and IVD companies obtain the CE Mark, implement ISO 13485 or GMP quality systems, submit FDA 510k applications, find medical distributors and more. With offices in the USA, Europe, Canada, Australia and China, we can assist you with most international quality and regulatory compliance issues.

Jaap Laufer, VP of Public and Regulatory Affairs to speak at 11th annual FDA/OCRA Conference in Irvine, CA on June 11-12 - Download PDF