MBTec provides engineering services for electro-medical devices development (MD, AIMD, IVD), either as : 1/ a full design contractor, in partnership with Evolution Medtec (www.evomedtec.com) . Get access to a multidisciplinary team of 20 experimented and innovative engineers in hardware (mechanical, electrical, optic) and software (familiar with EN 62304) to outsource your development in a very efficient and competitive manner. 2/ Operational consulting. We will contribute, upon your need, to development tasks like: - Project setup (roadmap, project quality plan, …) - Identification, when required, of partners (product design agency, specialized engineering company, testing laboratory, …). MBTec has an important professional network which eases the contacts. - Project management all along the V-cycle of stakeholders (internal or external) - Definition or review of user requirements, applicable standards - Investigation on concepts, evaluation of technical options. - Contribution to formalization of system architecture, detailed specifications (Hw & Sw), and all necessary design documentation (part of the Design History File). - Qualification support for conformity to standards and EC regulation, including interface with the testing laboratories Interested in working together ? or for any questions, please contact us : contact@mbtec.fr