Our MediaClin team advises, guides and supports you in the preparation of your clinical and regulatory documents, as well as in the design, coordination and validation of your clinical trials.
You wish to conduct a pre- or post-market clinical trial on one of your medical devices.
We support you at all stages of your project: strategic and methodological reflection, trial design, drafting of documents, regulatory submission, implementation, coordination and monitoring of the study, statistical analysis and evaluation of the results.
We train your collaborators to the normative and regulatory references applicable to your tests (ISO 14155 , ISO 20916, MDR 2017/745, IVDR 2017/746, …).
Trainings are available in French and in English.
Selection of investigation sites
Launching, follow-up, closing of the trial
Project coordination, Update, Archiving
You wish to design or update the clinical and regulatory documents of the technical file of one of your medical devices?
Our experts are here to assist you in defining the ideal clinical development strategy for your products, and support you in its implementation and monitoring.
Our resources are tailored to your needs: Strategic discussion, Documentary review and audit, Training or Document writing.
Design and update of clinical-regulatory documents:
You wish to be advised on the clinical development strategy for your products in the pre- or post-market phase, assess the clinical and regulatory compliance of documents relating to a specific medical device, discuss the conduct of a clinical investigation or simply learn about the clinical and regulatory requirements applicable to your device?
Regulatory compliance of documents related to a specific medical device, discuss the conduct of a clinical investigation or simply learn about the clinical and regulatory requirements applicable to your device?
Our team advises and assists you through working sessions dedicated to your projects. Face-to-face sessions, conducted in-person or remotely.
Check that your clinical trial is carried out according to the applicable regulatory and normative requirements.
We offer to audit your service providers (CROs, investigation sites, etc.) in order to demonstrate the compliance of your trial with the applicable standards.
In addition to the audit findings, we suggest ways to improve on the audited points.
ISO 14155 , ISO 20916, BPC, FDA, RDM 2017/745 “Annex XV”, RDIV 2017/746 “Annex XIII & XIV”
You operate in a demanding regulatory and normative environment. The efficiency of your employees is an essential element of your company’s performance.
We support you in the development and maintenance of your teams’ skills.
As a Qualiopi-certified training organization, CEISO offers customized training sessions, either in-person or in virtual classrooms, accessible to people with disabilities.
Thanks to its e-learning platform, CEISO allows the medical devices industry to benefit from a choice of regulatory and normative training courses, according to their needs – and in complete autonomy.
Clinical Evaluation / Clinical Investigation / Clinical Performance of In Vitro Diagnostic Medical Devices / Post-market follow-up
Clinical Evaluation / Clinical Investigation / Clinical Performance of In Vitro Diagnostic Medical Devices / Post-market follow-up
Does your problem concern the Clinic area?
We invite you to specify your needs via the contact form.
We will get back to you as soon as possible.
Consulting, Clinical Services, Training. We assist you in bringing your medical devices to market.
