MeDev Consulting ...make it easy!

At MeDev Consulting we help manufacturers, importers and startups to obtain the CE marking for medical devices and in vitro diagnostic products (IVD), complying with European regulations MDR (EU 2017/745) and IVDR (EU) 2017/746.

With more than 30 years of experience in medical products, we offer complete support for the certification and development of medical devices, including the management of manufacturing processes in accordance with ISO 13485, from the initial regulatory strategy to the launch on the European market.

We work with medical devices of all classes (I, Is, Im, IIa, IIb, III) and in vitro diagnostics (A, B, C, D), adapting each project to make the process more agile, clear and efficient.

👉 Specialized in medtech startups that need to launch their product in Europe with a solid regulatory strategy and without unnecessary delays.