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Studio Ambiente

Dossobuono di Villafranca di Verona, Veneto, Italy

Ownership: Private
Development stage: Other

Overview

Studio Ambiente is an Italian consultancy and laboratory service provider specializing in regulatory affairs for medical devices, pharmaceuticals, and cosmetics. The company assists clients with CE marking of medical devices under EU regulations, FDA 510(k) submissions for the US market, MDSAP certifications for global markets, quality management system certifications (ISO 9001/13485), product validation/testing in accredited labs (ISO/IEC 17025), and related technical documentation. They do not develop their own therapeutics or have clinical results.

Industry: Consulting

Partnerships

Various European/North American/Eastern European companies (clients)Italian Notified BodiesEuropean Notified Bodies

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