Studio Ambiente

Strategies for quality in biomedical field since 1996.

Studio Ambiente Srl is the ideal partner for specific regulatory consultancy, for your laboratory analyses, as well as for clean room analyses and for your product and process validations.
The experience gained over the years with several international customers, the professionalism, the specific skills and the internal organization allow us to assist you at 360 degrees, identifying the best regulatory and analytical strategies and to support you in the marketing of your Medical Device in the European Market, through obtaining the CE Mark in accordance with Directive 93/42/EEC and the new EU Regulation 2017/745.

Our consulting team is also specialized in Quality Management System Certifications such as ISO 9001, ISO 13485 and MDSAP for the certification in World’s top Markets.
All this thanks to the skills, the passion that is spent every day in our professional activity, the complete availability to the customer and the excellent problem-solving skills that have been developed over the years.
Our motto is “Strategies for quality in biomedical field” for this Studio Ambiente is the ideal partner in the identification of the best regulatory and analytical strategy for your Medical Device marketing in Europe and World’s top Markets.



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