Regulatory Requirements

Our team has extensive knowledge in worldwide requirements for in vitro diagnostic (IVD) products and medical devices, thus we are able to clear the hurdles on the journey to market access and advise on the most effective regulatory approval/clearance strategy for each individual product.

We are used to work on a global market and are experienced in achieving market authorizations such as 510(k) clearance (US), CE marking (EEA), Shonin approval (Japan), Medical Device License (Canada) etc.

Euro Diagnostica has been successful in ensuring Regulatory Product Compliance during the entire lifecycle, including risk management and post-production activities.

Complement Whitepaper 2016