Each category brings different opportunities for your product:
For medical devices:
For food supplements:
For foods for special medical purposes:
Vizera has a wealth of experience in clinical trials of medical devices and nutraceuticals and provides support with the EFSA claim submission. We also perform clinical trials for pharmaceuticals phase III and IV. We are highly skilled in several therapeutic areas, some of which include diabetes, prediabetes, wounds, gastroenterology, cognitive functions, paediatric health, the immune and cardiovascular systems, urology and gynecology.
Before a medical device is introduced to the market it must obtain the CE mark. Vizera is experienced in clinical evaluation report preparation as well as complete technical documentation. Vizera also helps you to make the right decisions on how to register your product in the EU in order to avoid incurring additional time and financial costs.
If you are interested in finding out more about regulatory affairs, you are kindly invited to complete the enquiry form below or send us an e-mail. All information you provide will be kept strictly confidential.