Tecno-med Ingenieros, S.L.

Spain

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Tecno-med Ingenieros, S.L. is a specialized medical engineering and regulatory compliance consultancy based in Barcelona, Spain, operating continuously since 1995. The company maintains an ISO 13485-certified quality management system specifically for medical device consulting services.

The company provides targeted engineering and regulatory consulting to healthcare hardware and software manufacturers, guiding products through the critical design and validation stages necessary to achieve CE marking under EU MDR/IVDR as well as FDA market clearance in the United States.

Offer

Tecno-med Ingenieros provides complete technical and regulatory preparation services across the medical device lifecycle:

Design Dossiers & Technical Documentation: Creation and review of technical documentation files pursuant to Annex II and Annex III of Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).
FDA Submissions: Consultation and compilation of FDA 510(k) applications, Q-Submissions, and FDA Establishment Registration & Listing.
Software Lifecycle & AI Compliance: Medical device software (MDSW) documentation and verification compliance according to EN 62304 and European Artificial Intelligence Act (AIA) integration for medical devices.
Risk & Usability Engineering: Risk management implementation under ISO 14971 and usability testing file compilation according to EN 62366.
Quality System Implementation: Design and auditing of Quality Management Systems conforming to ISO 13485 and MDSAP.
Authorized Representation & Registration: AEMPS licensing, Spanish RECOPS database registration, and European EUDAMED/UDI system registration.

Tecno-med Ingenieros, S.L.

Offer

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