Studio Ambiente has been supporting companies operating in the medical device sector for over 30 years, helping them obtain and maintain the product and quality system certifications required for market access and compliance.

Through its continuously expanding microbiological and physical testing laboratories, combined with up-to-date technical and regulatory consulting services, Studio Ambiente offers a comprehensive range of services, including:

- Microbiological testing of medical devices, raw materials, and packaging (bioburden testing, sterility testing, LAL testing, particle analysis);
- Validation of critical processes (sterilization, packaging, aseptic filling, depyrogenation, reprocessing of reusable medical devices, manufacturing cleaning processes, and more);
- Testing and monitoring of cleanrooms and controlled contamination environments (microbiological analysis of air and surfaces, particle counting, microclimatic parameter assessment, recovery tests, air change rate measurements, and more);
- Specialized technical consulting;
- Regulatory consulting for CE marking of Medical Devices.

The combination of technical expertise and a thorough understanding of regulatory requirements enables Studio Ambiente to deliver targeted, effective solutions that meet each client's specific needs.

Studio Ambiente is certified according to UNI EN ISO 9001:2015 and UNI EN ISO 13485:2021, operates an ISO/IEC 17025:2018 accredited testing laboratory, and is a Good Laboratory Practice (GLP) Test Facility certified by the Italian Ministry of Health.