Meditrial Europe is among the first CROs to achieve ISO 9001:2015 quality certification

Always focused on innovation, Meditrial Europe reaches a new milestone in achieving industry leadership in the field of clinical research and digital data management for the medical devices industry. The company is in fact among the first clinical research organizations (CRO) to be awarded ISO 9001:2015 certification, which represents an important accreditation as a highly qualitative organization with extensive internal procedures and committed to customer satisfaction. Created by the International Organization Standardization (ISO), the 2015 edition of ISO 9001 outlines the latest standards to be respected to demonstrate the quality of the products and services offered. Daniele Ceccarelli, legal manager of Meditrial, was very satisfied. He underlined how this goal represents “a confirmation of the excellent work done to achieve leadership in terms of results and innovation”.  Along the same lines, Dr. Monica Tocchi, Medical Director of the company, believes that the certification will positively influence customer trust, “Our clients will feel confident that a project entrusted to Meditrial will be managed with the utmost attention to the highest standards of required quality”.  Daniele Zago, R & D and Quality Manager who coordinated the project added that “the certification is the confirmation of the efforts made over the years for the creation of a solid system that meets customer demands in terms of costs, time management and, above all, quality of services “. The services offered by Meditrial Europe are now certified to comply with the new ISO 9001:2015 quality requirements. These services include: creating technical files for medical devices, conducting clinical evaluations and literature reviews, developing clinical protocols and investigator brochures, generating risk analysis, obtaining approval to conduct clinical studies in all European Countries, performing clinical study monitoring, and statistical analysis, all in accordance with standard ISO 14155. Moreover, Meditrial Europe provides data management software Catchtrial and Fastrial, supports companies in implementing the quality system for medical devices, and provides expert consulting and support to special projects involving new technologies. The combination of these elements strategically positions Meditrial Europe to be a distinctive, respected leader in the CRO sector serving the medical devices industry.

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