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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 Implantables 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. 

WHAT DO WE DO?

• CE Marking – EU Directives: Consultancy for Compliance

• Quality Management EN ISO 13485:2003

• Risk Management EN ISO 14971

• Clinical Evaluation EN ISO 14155

• Regulatory Affairs, Applications to Spanish Authorities

•  Authorized EU Representative

•  Experts in Notified Body Audits

 WE ARE EXPERTS IN:

 Technologies

• Sterilization (EtO, γ, β, steam)

• Clean Rooms

• Process Validation

• Biocompatibility

• Electromagnetic Compatibility

• Safety of Electromedical Devices

• Electronic Records and Signatures

• Computerized Systems and Processes

CE-Marking

• Technical Documentation (TF, STED)

• Consultancy for applicable standards, testing to be performed and recommended laboratories.

• Compliance with essential requirements

• Strategy and selection of conformity assessment routes

• Selection of Notified Body / Certification Body

• Supplier and subcontractor audits

• Clinical evaluation: Bibliographic review / clinical trial

Quality Systems

• Quality Systems documentation and implementation,

• Gap Analysis: adaptation and updating

• Compliance with regulatory requirements set out in the medical devices directives.

• ISO 9001:2000 Quality Management – Generic Standard

• ISO 13485:2003 Quality Management – Medical Devices

• QSR-GMP 21 CFR 820 Quality Regulation U.S.A.

• Independent periodical review audits

• Consultancy for Annual Quality System Reviews, quality policies, objectives and indicators.

• Support and collaboration during 3rd party Certification audits by Notified Bodies and Competent Authority inspections.

Risk Management

• ISO 14971 and Quality Management Systems integration

• Risk Management plans, reports and files.

• Product Audits – Periodical product reviews.

Regulatory Affairs

• Monthly follow-up meetings to control regulatory activities and communications with Competent Authorities.

• Consultancy for vigilance and incident / near-incident notifications

• Advisory Notices / Recalls

• Surveillance – follow-up actions and information on products in the post-market phase

• Publicity and promotion of medical devices

• Manufacturing / Import License Applications

• Distribution and selling authorization applications

• Competent Authority Notification when placing medical devices on the market

• Supply and Distribution Agreements

Training

• Annual Training Course Program (in-person/on-line)

• Training tailored to your needs

CONTACT PERSONS

LOCATION

Our company is located in Barcelona city from Catalonia, where are also installed most of the Spanish medical devices manufacturers

See the  Barcelona city map