Services: development, MDR/IVDR CE marking and industrialisation of medical devices

Over 30 years of regulatory consultancy and development of medical devices and in vitro diagnostics. At MeDev Consulting we support manufacturers, importers and startups from the idea to MDR/IVDR CE marking and manufacturing: regulatory strategy, technical file, ISO 13485, AEMPS, EUDAMED and RECOPS, and the development of the device with its hardware, firmware, software and mechanics.

We are not an engineering firm that later looks for someone to certify the product, nor a consultancy that only tells you what to do: the same team develops, validates, documents and industrialises. Always under a fixed, fast quote at every phase.