Allow us to introduce ourselves…
Tecno-med Ingenieros is a consultancy company with up to 20 years o 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 and In Vitro Diagnostics Devices. 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.
What do we do?
• CE Marking – EU Directives: Consultancy for Compliance • Quality Management EN ISO 13485 • Risk Management EN ISO 14971 – ISO 31000 • Clinical Evaluation EN ISO 14155 • Regulatory Affairs, Applications to Spanish Authorities • Experts in Notified Body Audits
We help you to:
- review the state of quality and regulatory compliance of your Spanish facilities according the European and Spanish Laws performing Quality & Regulatory Audits according EN ISO 13485:2016 and the new Medical Device Regulations.
- establish a regulatory strategy, device registration, quality management system compliance o your Spanish distributors and servicing providers.
We are experts in:
• Biocompatibility • Sterilization (EO, γ, β, steam, plasma) • Clean Rooms • Process Validation • Electromagnetic Compatibility • Safety of Electromedical Devices • Electronic Records and Signatures • Computerized Systems and Processes • Usability
• Technical File / 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 documentation and implementation • Gap Analysis: adaptation and updating • Compliance with regulatory requirements set out in the medical devices directives • ISO 9001 Quality Management – Generic Standard, in healthcare. • ISO 13485 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
• ISO 14971 and Quality Management Systems Integration for product and processes. • Risk Management plans, reports and files • Product Audits – Periodical product reviews
• 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
• Annual Training Course Program (in-person/on-line) • Training tailored to your needs
Please send us an e-mail for more information about our services.