From strategic consulting to post-market follow-up, CEISO is always by your side, making sure every box is ticked as you work toward the commercialization of your products.Audits CE Marking Regulatory watch Biocompatibility
For almost 25 years, CEISO has been supporting companies in the medical sector in the design, development, and post-market monitoring of their projects.
CEISO ensures the same quality of service and proximity to all its clients, whether it’s international biomedical and pharmaceutical companies or small-scale innovative companies.
Quality, Regulatory, Clinical, Training, Mandate, PRRC: CEISO puts its highly qualified team to the service of your products, all along their lifecycle.
“Mastering the future”… For us, that means anticipating changes in regulatory and normative texts that may have an impact on your activities or your company’s strategy.
In other words: understanding tomorrow’s rules — today! CEISO provides you with the necessary tools to achieve this goal.
CEISO draws its strength from the men and women behind its highly-qualified team.
Our collaborators all come from Notified Bodies and certification organizations, be it from the research or health industry sector.
The multidisciplinary nature of the team ensures complementarity between all CEISO activities.
CEISO supports its French and international clients in bringing medical devices to market, thanks to our consulting services, clinical department, training center and market access services.
Days of consultancy and clinical intervention.
On-site visits per year.
Clients in France and internationally.
People trained annually.
As a certified training organization for over 15 years and Qualiopi-certified since January 2021, CEISO offers customized training sessions, in-person or virtually, either individually or as a group. Our trainings are also accessible to people with disabilities.
CEISO provides the medical device industry with a range of regulatory and normative training courses through its e-learning platform, according to the needs – and independently.
Designing, producing, and commercializing Medical Devices in Europe must be carried out in accordance with the requirements of Regulation (EU) 2017/745.
The stakeholders in this market must be able to assess the impact of these requirements on the compliance of their products, on the information to be provided in the technical files, and on their organization in order to define a compliance action plan.
This training will allow you to update or acquire practical knowledge, identify and control risks related to the use of medical devices in accordance with the recommendations of the ISO 14971:2019 standard.
Demonstration of product compliance with the general requirements of Regulation (EU) 2017/746 may include a clinical performance study aimed at producing data to clinically establish or confirm the analytical performance of a device. The objective of this training is to identify the regulatory obligations to establish and conduct a clinical performance study.
The EUDAMED & IUD module presents the EUDAMED database and its various identifiers.
The module consists of a course in the form of an interactive video with voice-over and educational activities. The module is available 24/7. Follow-up reminders are sent to ensure progress tracking and prevent learning disruptions.
The Post-Market Surveillance & Vigilance module focuses on the importance of post-market surveillance and which procedures should be put in place according to the type of data collected.
Your problem concerns Regulatory Quality, Clinical Services, Training, or Market Access?
We invite you to specify your needs via the contact form.
We will get back to you as soon as possible.