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.
...make it simple!
At MeDev Consulting we help manufacturers, importers and startups with the regulation, quality and industrialization of medical devices.
Technical documentation and quality systems adapted to the new regulation. Simple, robust and efficient!
Learn moreImplementation and support for EN ISO 13485 and EN ISO 9001 certifications. Compliance guarantee!
Learn moreAEMPS manufacturing and import licenses and registration of economic operators in EUDAMED.
Learn moreValidation of critical processes and sterilization methods under international standards.
Learn moreExternal audits and technical evaluation of critical suppliers for your supply chain.
Learn moreComprehensive management: from prototype to manufacturing, quality control and logistics.
Learn moreThe guarantee of safety in medical devices. Certification under MDR and IVDR.
Learn moreCompanies that have placed their trust or collaborate with MeDev for the management of their medical devices or IVDs.
Stay up to date with innovations and developments in the sector.
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   MedTech Europe* pone a disposición una plantilla de Declaración del fabricante para facilitar la declaración de lo...
Read moreAt MeDev Consulting we help manufacturers, importers and startups with medical device regulation. Call us or send us a WhatsApp and we will assist you as soon as possible.