Tecno-med Ingenieros is a consultancy company located in Barcelona, Spain. Our goal is to provide regulatory support and expert advice for manufacturers, importers, distributors and exporters of medical devices as well as all associated service providers.
We are specialists in the technical and regulatory requirements of the three principal European Directives for Medical Devices 93/42/EEC, In Vitro Diagnostics 98/79/EEC and Active Implantable 90/385/EEC.
Our group comes from an engineering background with more than 20 years technical experience within industry. Hands-on application of the requirements and constant specific training allow us to maintain close relations with Notified Bodies, Certification and Standardization Entities, Accredited Laboratories and Universities.
Currently, we provide services for most of the Spanish manufacturers and dealers. If your company requires compliance with European regulations, contact us; we can help you meet your objectives
We are specialists in the technical and regulatory requirements of the three principal European Directives for Medical Devices 93/42/EEC, In Vitro Diagnostics 98/79/EEC and Active Implantable 90/385/EEC.
Currently, we provide services for most of the Spanish manufacturers and dealers. If your company requires compliance with European regulations, contact us; we can help you meet your objectives
La @AEMPSgob lanza la aplicación RPS de registro de responsables de la puesta en el mercado de productos sanitarios
Tecno-med Ingenieros
Boletin @AEMPSgob 3T 2021 de productos sanitarios y cosméticos
Tecno-med Ingenieros
MDCG: nueva MDCG 2021-25 Aplicación de los requisitos de MDR a los productos ‘legacy’ y a los productos ‘old’
Tecno-med Ingenieros
la @AEMPSgob traduce la MDCG 2019-15 rev1 Guia para fabricantes de productos sanitarios clase I
Tecno-med Ingenieros
Publicada la primera lista de normas armonizadas con MDR – Decisión de Ejecución 2021/1182
Tecno-med Ingenieros
@MedtechEurope ( @FENIN_es ) publica el informe 'The European Medical Technology Industry in figures 2021'
Tecno-med Ingenieros
La AEMPSgob publica el texto del proyecto de Real Decreto por el que se regulan los productos sanitarios
Tecno-med Ingenieros
COVID19 FAQ regulatorias – La Comision publica su preguntas y respuestas de los tests COVID-19 y una base de datos de tests IVD
Tecno-med Ingenieros
BREXIT – La @MHRAdevices establece en el MDIS (Medical Device Information System, su Eudamed) el uso de códigos GMDN
Tecno-med Ingenieros
BREXIT: puedes leerte el acuerdo entre UK y Europa
Tecno-med Ingenieros
