TECNO-MED Ingenieros

Presentation

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

Services

Our company offers the following services:

 CE-marking according to Medical Technologies Directives 

 Quality Management Systems ISO 13485

 Risk Management ISO 14971

 Clinical Evaluation ISO 14155 – MEDDEV 2.7/1

 Medical Software EN 62304 

 Vigilance Systems (Incident Reports, FSCA, FSN, ...) – MEDDEV 2.12/1

 Advice in FDA CDRH (USA) - Preparation of 510(k) premarket notification

 Regulatory Affairs -  Procedures Management relating to Medical Devices

- Manufacturer's License (AEMPS - Spain)

- Reporting and Communications: PMPS, RPS (AEMPS - Spain)

- Reporting of Distribution Activities to Regional Health Authorities (Spain)

- Manufacturer's License (Custom-made Medical Devices) - Regional Health Authorities (Spain)

 European Authorized Representative

 Experts in Notified Body Audits

 Training in the Regulatory Environment of Medical Devices