Emergo Group


Emergo's roots go back to 1997. Rene van de Zande, CEO of Emergo, founded the company shortly after the implementation of the new European Medical Devices Directive (93/42/EEC).

His goal was to help US medical device companies obtain CE Marking and export their products to Europe.

Since then, Emergo has expanded to become a leading consultancy with more than 2,800 medical device and IVD clients worldwide. Today, we maintain offices in 25+ countries, offering a wide range of compliance services.

We assist companies with regulatory strategy, device registration, quality management system compliance and in-country regulatory representation.


2500 Bee Cave Road, Bld 1, Suite 300
Austin, Texas 78701
United States

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