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.