Training program on EUDAMED registration and national medical device regulatory requirements. Covers MDR/IVDR compliance, quality system documentation, clinical evaluation strategies, and national licensing procedures for manufacturers, importers, and distributors. Designed for regulatory and qualit...
Manufactured by
Tecno-med Ingenieros, S.L.
Barcelona, Spain
Tecno-med Ingenieros is a consultancy company with up to 30 years of 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. Ed. Triangle, Pza Cataluña num.1, 4º ES08002 Barcelona.
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CMC Medical Devices & Drugs S.L. · Spain
EUDAMED registration consulting service supporting medical device manufacturers with European regulatory compliance, market access strategy, and submission documentation. Delivers tailored guidance for navigating EUDAMED database requirements and harmonized standards across EU markets.
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Training and consulting services for medical device regulatory compliance, including technical documentation creation, MDR file management, and quality assurance strategies. Supports healthcare professionals in navigating EU 2017/745 regulations and preparing submissions for Notified Bodies.
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EUDAMED is the European database on medical devices that supports regulatory compliance and CE marking for medical device manufacturers. This service provides access to EU regulatory information and documentation requirements for device conformity assessment and market approval.
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