Who we are

Studio Ambiente S.r.l. was formally founded in 2004, as a corporate transformation of the previous Studio Ambiente by Rossignoli Emanuela, which had been active since 1996.

The specific miission of Dott.ssa Emanuela Rossignoli was to offer a technical and regulatory consulting service to small/medium companies, at the time operating in medical and surgical devices field (PMC), in order to comply with the new Directive 93/42/EEC.

Over the years, supported by collaborators with acquired experience, Studio Ambiente has expanded its consulting activities, in addition to the medical devices sector, also to the pharmaceutical and cosmetic products sectors, specializing in the development of company quality systems and in the drafting of technical product file.

Today, Studio Ambiente’s consulting offer covers all the documentary and strategic activities for obtaining product certification, in the European and not EU markets.

Since 1997, the consultancy activity has been supported by a microbiological laboratory for the execution of sterility test of biological indicators and products, for the execution of bioburden tests and estimation of the microbial load and for the validation of sterile barrier systems. The laboratory furthermore carries out validation of production environments, validation of sterilization and packaging processes.

Since 2002, the laboratory has been certified as operating in Good Laboratory Practice (GLP) for the execution of certain types of non-clinical studies on products.

In February 2006, the company moved to current headquarters in Dossobuono di Villafranca, increasing the operative space and implementing the analytical offer through the acquisition of new specialized equipment and technical staff.

In September 2008 Studio Ambiente S.r.l. obtained ISO 9001 and ISO 13485 certification to offer its customers:

• Consultancy in the biomedical field;
• Microbiological analysis services on products;
• Development of process validation protocols;
• Clean rooms analysis;

Through and thanks to the relationship with customers, from different European, North American and Eastern European companies and through the collaboration with different Italian and European Notified Bodies, the experience and the competences of Studio Ambiente have been enriched over the years, permitting to the staff and collaborators of Studio Ambiente to accumulate heterogeneous knowledge on different types of products, in order to offer all-round assistance to companies in the biomedical sector.