From idea to CE marking: medical device development, industrialisation and regulatory consultancy

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.

Over 30 years of experience in regulatory consultancy and development of medical devices and in vitro diagnostics. We support you from the initial regulatory strategy and product development (hardware, firmware, software and mechanics) to CE marking, ISO 13485 manufacturing and placing on the European market.

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.

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.