Tecno-med Ingenieros SL
Spain, Portugal, UK, France, Belgium, Italy, Germany, Uruguay, Argentina, Brazil.
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 for Medical Devices and In Vitro Diagnostics Devices. 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.
Areas of regulatory/reimbursement support:
Compliance with regulatory requirements set out in the medical device directives and new medical device regulations, Quality Management System, Risk Management, Selection of notified body/Certification Body, Clinical Evaluation, Support and collaboration during 3rd party Certification audits by Notified Bodies and Competent Authority, Usability CE-Marking, Safety of electromedical devices, Strategy and selection of conformity assessment routes