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Tecno-med Ingenieros is a consultancy company with more than 25 years of experience 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 for Medical Devices Regulation and In Vitro Diagnostics Devices Regulation. Our group comes from an engineering background with more than 30 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

– CE Marking – EU Regulations Consultancy,
– Quality Management EN ISO 13485. MDSAP. 21CFR820 – Risk Management EN ISO 14971 – ISO 31000
– Clinical Evaluation Reports and plans according MDR / IVDR – Clinical investigations EN ISO 14155.
– Regulatory Affairs. NB and Health Authorities communications – Applications to Spanish Databases
– Experts in Notified Body Audits
– Training

TECNO-MED, TECNOLOGIAS SANITARIAS