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 and 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.
To these companies, Coronati Consulting aims to provide a highly specialized Consulting service and a complete and targeted laboratory service for the CE marking of Medical Devices.
Due to the fulfillment of the following requirements:
- Strong specialization of the service offered in order to meet customer needs in accordance with the production and organizational reality in which it operates.
- Implementation of interventions that fully comply with the regulatory requirements inlcuded in pharmacopoeias, standards, guidelines, directives and other applicable laws, as well as with what has been agreed with the customer.
- Maximum collaboration, courtesy and availability to the customer.
- Impartiality and Confidentiality in the management of the data and information received.
The high degree of specialization of the services offered and the competence of the staff constitute the base of Coronati Consulting’s activity.
These requirements are translated into objectives at all levels of the organization.
This implies that:
- Our organization is UNI EN ISO 9001 certified for the General Quality System and UNI EN ISO 13485 for the Medical Quality System. The laboratory is also accredited by UNI CEI EN ISO / IEC 17025 by ACCREDIA.
- Our suppliers of products / services are selected according to their ability to meet our needs and qualified.
- The staff is chosen with a high degree of school preparation, adequately trained both internally and with external specialization courses.
- Continuous and direct contact with customers makes it possible to collect all the information necessary for the continuous improvement of the service offered and the satisfaction of the specific needs of the customer in compliance with the applicable requirements.
- The cost / quality ratio of the services offered is always the subject of the utmost attention.
- staff are strongly motivated to observe and respect the safety and the workplace environment.
- Compliance with all applicable fiscal, administrative and financial laws is the subject of the utmost attention by all staff and in particular by Management.
Significato dell’Accreditamento ISO/IEC 17025:2005
List of accredited test Rev.10 (2020)
Certificato ISO 17025_Rev.02 (exp. 12_2022)