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


  • Area of Activity
  • Quality control
  • Consultancy
  • Company type
  • Services and consulting for biotech sector
Office
Spaces Retiro, C/ Alfonso XII num.62
BARCELONA, Madrid 28014, ES
P: +34 91 0767142
E:info@tecno-med.es
Headquarter
Ed. Triangle, Pza Cataluña num.1
Barcelona, Barcelona 08002, ES
P: +34 932 917 739
F:
E:info@tecno-med.es

Xavier Canals-Riera Director, EurIng Ing. Telecom xcanals@tecno-med.es cel. 608946551

Claire Murphy, Partner and Consultant, Ing. Electronico cmurphy@tecno-med.es cel. 687506313

Isabel Rodríguez irodriguez@tecno-med.es

Ana Budia abudia@tecno-med.es

Rosmar Franceschini rfranceschini@tecno-med.es

Candela Meneguzzi cmeneguzzi@tecno-med.es

Customer Service (Offers and planning)

Angeles Enamorado aenamorado@tecno-med.es

Administration

Dori Rey drey@tecno-med.es

Training Manager

Xavier Fontanals xfontanals@tecno-med.es

  • CE Marking Medical Devices Regulations MDR and IVDR
  • Quality Systems EN ISO 13485
  • Risk Management EN ISO 14971
  • Clinical Evaluation EN ISO 14155 - MEDDEV 2.7/1
  • Medical Software EN 62304, EN 82304
  • Surveillance Systems (incident reporting, FSCA, warning notes,...)
  • FDA CDRH consultancy - 510(k) dossier preparation
  • Regulatory Affairs and Management of Medical Devices
  • Manufacturer licenses AEMPS
  • RC, CCPS, RPS communications AEMPS
  • Communications distribution and sales to AASS CCA
  • Tailor-made medical devices manufacturer licenses in AASS CCAA
  • Experts in Notified Body audits
  • Health Technologies Sector Training

-Independent team

-Demonstrated experience as health care consultants

-Expertise in applied regulations

-Dedication to all our clients

At this moment, we have the confidence of most of the companies in the sector so we can offer you an independent, efficient and adjusted service to your company.

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

Tecno-med Ingenieros