MBTec

MBTec provides engineering services for electro-medical devices development (MD, AIMD, IVD), either as : 1/ a full design and manufacturing contractor, in partnership with Cicor Medtec (https://www.cicor.com/en/markets/medical-technology/) . Get access to a multidisciplinary team of experimented and innovative engineers in hardware (mechanical, electrical, optic) and software (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 (industrial design agency, 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