Our Services
At MeDev Consulting we help manufacturers, importers and startups to obtain CE marking, comply with MDR/IVDR regulation and bring their medical devices to the European market.
TF & QMS MDR/IVDR
Preparation of technical documentation and quality systems adapted to the new MDR/IVDR regulation. Simple, robust and efficient.
Learn moreCertifications ISO 13485
Expert advice for EN ISO 13485 and EN ISO 9001 certification. Implementation of processes that guarantee regulatory compliance.
Learn moreLicenses AEMPS - EUDAMED
Comprehensive management of manufacturing and import licenses before the AEMPS and registration of economic operators in EUDAMED.
Learn moreValidations EtO/BETA/GAMMA
Validation of critical processes and sterilization methods (EtO, BETA, GAMMA) according to applicable international standards.
Learn moreAudits SUPPLIERS
Execution of external audits and technical evaluation of critical suppliers to ensure the quality of your supply chain.
Learn moreIndustrialization DEVICES
From prototype to series: comprehensive management of manufacturing, assembly, quality control and specialized logistics.
Learn moreMD and IVD Symbol CE MARKING
The guarantee of safety in medical devices. Certification and CE marking under MDR and IVDR regulations.
Learn moreNeed a custom solution?
We help manufacturers, importers and startups find the best regulatory strategy for their medical devices.