Coronati Consulting Srl was born in January 2001, but its origin dates back to 1995 when Dr. Renzo Coronati decided to start its own activity. The company has many years of experience in the medical sector and deals with two main activities: CONSULTANCY and LABORATORY SERVICES.

 

Our team of experts supports companies to obtain the CE Marking of medical devices and the realization of Quality Systems in accordance with ISO 9001 and ISO 13485 standards. Qualified laboratory technicians perform laboratory tests for the qualification of medical devices, routine tests on products for the release on the market and validation of critical processes (clean room validation, packaging validation, cleaning / washing validation and microbiological validation of sterilization processes).

Laboratory services

The Coronati Consulting Lab laboratories are divided into areas equipped with all equipment and instrumentation based on the specific activities carried out.

Chemical tests

Microbiological tests

Surgical mask tests

Bio-toxicological tests

Measuring laboratory

Packaging tests

Other tests

Consultancy services

Quality system

CE marking

Free sale certificate (FSC)

CE conformity

Registration and repertory (RDM)

Quality Policy

Coronati Consulting was born to meet particular needs of small and medium-sized companies in the Medical and Biomedical sector such as the implementation of a Quality management System according ISO 13485 – ISO 9001, the compliance to the Essential Requirements of the Medical Devices Directive 93 / 42 / EEC and European Regulation 745/2017 (MDR) for CE marking.

Coronati Consulting apply a Quality System certified in accordance with the requirements of ISO 9001 and ISO 13485 specific for medical device field.

Coronati Consulting has obtained accreditation of its laboratory according to UNI CEI EN ISO / IEC 17025, (n°1496) by ACCREDIA.

 

At the following links is it possible to download the Certificates, the list of accredited tests and the meaning of accreditation. The standard is commonly referred to as ISO 17025 and is recognized in all countries of the world. To check accreditation and the list of accredited tests, visit the website: www.accredia.it

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About us

Coronati Consulting was born in January 2001, but its origin dates back to 1995 when Dr. Renzo Coronati, former manager of an important multinational in the field of hemodialysis biomedical district of Mirandola with the function of Director Technician, Quality Assurance and Regulatory Affairs Manager, decided to start its own activity.