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CEISO, a certified organization!

CEISO chose to have the efficiency and conformity of its Quality Management System evaluated and recognized by a third party for all its activities, according to the ISO 9001 and ISO 13485 standards.

CEISO designs and organizes training courses, within organizations and beyond, on topics related to Medical Devices and In Vitro Diagnostic Medical Devices. CEISO has received the Qualiopi certification for all its training actions.

Our certifications

ISO 13485 - Quality Management System for Medical Devices and In Vitro Diagnostic Medical Devices

CEISO is ISO 13485 certified by AFNOR Certification for the following activities:

  • Consulting services for the development and/or submission of technical and regulatory files to competent organizations, biological evaluation of medical devices, training on applicable regulatory and/or normative requirements, assistance in the implementation of a quality management system, conducting audits: regulatory and normative monitoring, in the areas of medical devices and In Vitro diagnostic devices.
  • Establishment of clinical evidence demonstration strategy pre- and post-CE marking.
  • CRO (Contract Research Organization) and regulatory services to medical device manufacturers for complete management of all regulatory and clinical aspects of pre- and post-marketing clinical investigations for CE marking.European representative service under article 11 of regulation 2017/745.
  • Person responsible for ensuring compliance with regulations under article 15 of regulation 2107/745.

 

CERTIFICAT ISO 13485_CEISO

ISO 9001 - Quality Management System

CEISO is ISO 9001 certified by AFNOR Certification for the following activities:

  • Consulting services for the development and/or submission of technical and regulatory files to competent organizations, biological evaluation of medical devices, training on applicable regulatory and/or normative requirements, assistance in the implementation of a quality management system, conducting audits; regulatory and normative monitoring, in the areas of medical devices and In Vitro diagnostic devices and CRBs (biological resource centers), and for companies in the cosmetics industry.
  • Establishment of clinical evidence demonstration strategy pre- and post-CE marking.
  • CRO (Contract Research Organization) and regulatory and clinical services for pre- and post-marketing clinical investigations for CE marking.
  • European representative service under article 11 of regulation 2017/745.
    Providing experts responsible for ensuring compliance with regulations under article 15 of regulation 2017/745.

 

CERTIFICAT ISO 9001_CEISO

Qualiopi Certification

CEISO has been Qualiopi certified for its training activities since January 2021.

Law n°2018-771 of September 5th, 2018 on the freedom to choose one’s professional future includes in its article 6, for organizations carrying out actions contributing to the development of skills based on a unique national framework, the obligation of certification by a third-party organization.

The Qualiopi certification aims to attest to the quality of the process implemented by providers of actions contributing to the development of skills. CEISO has chosen Qualiopi certification for its training services by a recognized certification organization and has been Qualiopi certified since January 2021.

Qualiopi_2021-2024_CEISO

CIR Accreditation

CEISO is approved for Research Tax Credit (CIR).

The research tax credit (CIR) is a fiscal support device for research and development activities of companies. Its aim is to encourage them to develop their research and development activities by providing them with fiscal aid.

The company benefiting from the CIR therefore offers a significant advantage to its customers by allowing them to be reimbursed for part of the services invoiced.

Agrément_CIR_23_27_CEISO

Consulting, Clinical Services, Training. We assist you in bringing your medical devices to market.

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